This document discusses generic glaucoma medications. While generics do not need to demonstrate bioequivalence like systemic drugs, evidence suggests they may differ from brands in composition and efficacy. Specifically, one study found generic latanoprost reduced IOP less than the branded Xalatan. Differences in inactive ingredients between generics and brands before 1992 may also impact tolerability and efficacy. Close monitoring of IOP is recommended when switching patients to a generic drug.
The document discusses new cardiovascular drugs that are entering the market to treat high cholesterol and blood thinning. Praluent and Repatha, new PCSK9 inhibitor injections for cholesterol, are the current front-runners but face pricing pressures. Older generic drugs have established safety profiles that some physicians prefer over new drugs. New oral blood thinners also face adoption challenges due to the familiarity of warfarin despite offering simpler dosing. Future oral drugs for cholesterol like anacetrapib and ETC-1002 may have advantages over injections if approved.
The document provides information about generic and brand name drugs, including:
1) Generic drugs have the same active ingredients as brand name drugs but are cheaper because they do not require extensive research and development costs.
2) While generics must be proven to deliver the same amount of active ingredients as brand names, they are allowed to have different inactive ingredients and appearances.
3) Choosing a generic over a brand name drug can significantly reduce out-of-pocket costs through lower co-pays and prices, though insurance plans may steer patients toward generics.
This document provides an overview of glaucoma, including its anatomy, pathophysiology, classification, and pharmacological treatment. Glaucoma involves progressive optic neuropathy and vision loss due to increased intraocular pressure. It is classified into primary and secondary types. The main drugs used for treatment are prostaglandin analogues, beta blockers, alpha agonists, cholinergic agonists, and carbonic anhydrase inhibitors, which work to reduce aqueous humor production or increase outflow. Emerging therapies aim to provide neuroprotection to retinal ganglion cells. Surgery may also be used in some cases.
The document discusses Veloxis Pharmaceuticals, a pharmaceutical company developing LCP-Tacro, a novel formulation of the immunosuppressant tacrolimus for organ transplantation. It provides an overview of Veloxis' strategy, the market opportunity for LCP-Tacro, positive phase 3 clinical trial results showing LCP-Tacro is non-inferior to Prograf with a possible trend toward superiority, and plans for commercializing LCP-Tacro in the US and partnering ex-US. Financial projections are also presented.
One mans supergeneric is anothers life cycle managementMalcolm Ross
This document discusses the potential for generic pharmaceutical companies to develop "supergeneric" or value-added generic drug products. It provides examples of how simple reformulations or new delivery methods for off-patent drugs could create differentiated products with improved efficacy or compliance compared to existing generics. Developing combination products or modified release formulations are presented as opportunities requiring relatively little investment that leverage existing technical skills at generic companies.
The document discusses the risks and considerations around generic substitution of brand name antiepileptic drugs. It notes that while generics may reduce costs, generic AEDs may not be therapeutically equivalent to the brand name versions due to differences in bioavailability and potential problems from changes in drug levels. The document recommends against substituting brand AEDs with generics, especially for patients with well-controlled epilepsy, due to the serious risks of seizure recurrence or increased side effects from changes in drug concentrations.
The document discusses new cardiovascular drugs that are entering the market to treat high cholesterol and blood thinning. Praluent and Repatha, new PCSK9 inhibitor injections for cholesterol, are the current front-runners but face pricing pressures. Older generic drugs have established safety profiles that some physicians prefer over new drugs. New oral blood thinners also face adoption challenges due to the familiarity of warfarin despite offering simpler dosing. Future oral drugs for cholesterol like anacetrapib and ETC-1002 may have advantages over injections if approved.
The document provides information about generic and brand name drugs, including:
1) Generic drugs have the same active ingredients as brand name drugs but are cheaper because they do not require extensive research and development costs.
2) While generics must be proven to deliver the same amount of active ingredients as brand names, they are allowed to have different inactive ingredients and appearances.
3) Choosing a generic over a brand name drug can significantly reduce out-of-pocket costs through lower co-pays and prices, though insurance plans may steer patients toward generics.
This document provides an overview of glaucoma, including its anatomy, pathophysiology, classification, and pharmacological treatment. Glaucoma involves progressive optic neuropathy and vision loss due to increased intraocular pressure. It is classified into primary and secondary types. The main drugs used for treatment are prostaglandin analogues, beta blockers, alpha agonists, cholinergic agonists, and carbonic anhydrase inhibitors, which work to reduce aqueous humor production or increase outflow. Emerging therapies aim to provide neuroprotection to retinal ganglion cells. Surgery may also be used in some cases.
The document discusses Veloxis Pharmaceuticals, a pharmaceutical company developing LCP-Tacro, a novel formulation of the immunosuppressant tacrolimus for organ transplantation. It provides an overview of Veloxis' strategy, the market opportunity for LCP-Tacro, positive phase 3 clinical trial results showing LCP-Tacro is non-inferior to Prograf with a possible trend toward superiority, and plans for commercializing LCP-Tacro in the US and partnering ex-US. Financial projections are also presented.
One mans supergeneric is anothers life cycle managementMalcolm Ross
This document discusses the potential for generic pharmaceutical companies to develop "supergeneric" or value-added generic drug products. It provides examples of how simple reformulations or new delivery methods for off-patent drugs could create differentiated products with improved efficacy or compliance compared to existing generics. Developing combination products or modified release formulations are presented as opportunities requiring relatively little investment that leverage existing technical skills at generic companies.
The document discusses the risks and considerations around generic substitution of brand name antiepileptic drugs. It notes that while generics may reduce costs, generic AEDs may not be therapeutically equivalent to the brand name versions due to differences in bioavailability and potential problems from changes in drug levels. The document recommends against substituting brand AEDs with generics, especially for patients with well-controlled epilepsy, due to the serious risks of seizure recurrence or increased side effects from changes in drug concentrations.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
Clinical and Pharmacoeconomic analysis was extensivley done on Eylea for its placement on a hypothetical health plans formulary for Macular Degeneration. Information was presented to a panel of pharmacy professionals in managed care and industry
The document discusses generic drugs and biosimilars. It provides biographical information about the speaker and outlines key questions about generics that will be addressed. Generic drugs are defined as comparable but not identical to brand name drugs in dosage, strength, quality and performance. Biosimilars are similar to biologic drugs but require more extensive testing than generics due to their complex nature. The market for generic drugs is large and growing, particularly in emerging markets, as major drugs lose patent protection.
This document provides background information on counterfeit and substandard drugs, with a focus on paracetamol tablets sold in Nigeria. It discusses how counterfeit drugs are prevalent worldwide, especially in developing countries, and the health risks they pose. In Nigeria, the National Agency for Food and Drug Administration and Control regulates drugs and has taken steps to curb counterfeits. The document then outlines the aims of analyzing different brands of paracetamol tablets sold in Lagos to evaluate their potency and efficacy. Various quality tests are described, including appearance, weight, hardness, and dissolution rate.
A Study On The Portfolio O Drugs Recommended For Neurologial DisordersSaumya Agarwal (Sam)
The document summarizes a study on recommended drug portfolios for various neurological disorders. Key findings include:
- The study analyzed the preferred drug choices of 41 doctors in Hyderabad for diseases like epilepsy, Alzheimer's, psychosis, migraine, insomnia, depression and Parkinsonism.
- The proposed drug portfolio for each disease is based on the preferred molecules identified from the doctors' responses. For example, the portfolio for epilepsy includes Divalproex, Clobazam, Oxcarbazepine, Levetiracetam, Lamotrigine and Clobazam.
- Reasons for switching prescriptions between molecules/brands included severity of disease, adverse drug reactions, patient response
A Study On The Portfolio O Drugs Recommended For Neurologial DisordersSaumya Agarwal (Sam)
The document summarizes a study on recommended drug portfolios for various neurological disorders. Key findings include:
- The study analyzed the preferred drug choices of 41 doctors in Hyderabad, India for diseases like epilepsy, Alzheimer's, psychosis, migraine, insomnia, depression and Parkinsonism.
- The proposed drug portfolio for each disease is based on the preferred molecules identified from the doctors' responses. For example, the portfolio for epilepsy includes Divalproex, Clobazam, Oxcarbazepine, Levetiracetam, Lamotrigine and Clobazam.
- Reasons for switching prescriptions between molecules/brands included severity of disease, adverse drug reactions,
April 2009 Community Call
When integrated medication processes and automated cabinets are in place, pharmacists are enabled to practice more “clinical pharmacy”. Often this means getting pharmacists out of the basement and onto the floors where they are available to patients and their caregivers. One of pharmacy’s services is to promote a safe, effective, and economical list of preferred drugs. With well-designed EHR technology as a tool, pharmacists can proactively influence physicians to choose the “right” drug. They can also measure and report on compliance to formulary preferences. The goal of this session is to explore the options available and present experience with a program currently in place at one of our ecosystem sites.
This topic is both clinical and administrative in nature and will likely be useful to all pharmacy staff, clinical specialists involved in building/maintaining CPOE systems, physicians, nurses and others interested in pharmacy management, both from a clinical and fiscal perspective.
Please feel free to forward this invitation to any colleagues or associates who you believe would find this topic of interest or would like to participate in the discussion.
What: Pharmacy-driven Clinical Transformation
- Strategic Drug Selection
- What is it?
- Why do it?
- How can it be done?
- How is it measured?
- Who has done it?
- Transformation Working Group Update
- Review of status
- Open Project Updates
- OpenVista/GT.M Integration
- CCD/CCR collaboration
- Medsphere.org: Tip of the month
When: April 23, 12:30 - 2pm Pacific
Where: Dial-in: (888) 346-3950 // Participant Code: 1302465
Web conference: http://www.medsphere.com/infinite/
===
The community calls are listed on the Medsphere.org event calendar (http://medsphere.org/community-events/) and we will update each month's call as the agenda is solidified.
Details and Recording here: http://medsphere.org/blogs/events/2009/04/23/community-call-april-2009
The document summarizes trends in research and development of generic drugs in the global pharmaceutical industry. It provides an overview of historical developments in generic drug maker PLIVA dating back to 1928, and its combination with Barr Group in 2006 to form a global generic pharmaceutical company. It also discusses trends in the generic drug market, strategies for differentiation, and key factors for success in generic drug research and development, emphasizing the importance of speed, intellectual property positioning, and internal API development capabilities.
This document summarizes recent advances in treating age-related macular degeneration (AMD). It discusses new drugs that aim to prevent retinal damage or slow AMD progression by inhibiting angiogenesis, inflammation, the complement pathway, oxidative stress, and retinal toxin accumulation. It also describes surgeries like maculoplasty and bionic eye implants, as well as rehabilitation techniques and low vision aids. Promising new drug classes discussed include anti-angiogenics, complement inhibitors, neurotrophic factors, and antioxidants.
Glaucoma is a group of eye diseases characterized by optic nerve damage often associated with elevated intraocular pressure (IOP). Risk factors include increased IOP, age, family history, race, and diabetes. Goals of treatment are to lower IOP, control IOP fluctuation over 24 hours, and preserve vision while balancing medication efficacy and side effects. Common glaucoma drug classes lower IOP by decreasing aqueous humor production or increasing outflow, and are dosed 1-3 times daily with possible side effects like redness, fatigue, and drowsiness. Plateau iris syndrome is when the iris remains occluded after iridotomy due to anteriorly positioned ciliary processes; argon laser peripheral iridoplasty
The document describes an in vitro bioequivalence study of Glimepiride using biorelevant media. The aim was to evaluate the dissolution rate of Glimepiride in different biorelevant media, compare the bioequivalence of local generic brands to an innovator brand, and predict the effect of food in the GI tract on dissolution. Dissolution studies were conducted in four biorelevant media with two tablets each of three brands. Results showed that dissolution was highest in the intestinal medium and reduced with food. Difference and similarity factors indicated the two generic brands were equivalent to the innovator brand. Using biorelevant media allowed prediction of dissolution rates and bioequivalence of the Glimepiride brands.
The biologic drug actemra® to dramatically increase the benefit of rheumatoid...Biosimilars
The document summarizes a study showing that the biologic drug Actemra is superior to Humira for rheumatoid arthritis patients receiving monotherapy treatment. The study found that after 24 weeks, patients receiving only Actemra showed greater improvement in reduced symptoms like joint swelling and inflammation compared to those receiving only Humira. These results provide physicians an improved treatment option for patients who cannot take methotrexate with their biological drug.
Generic drugs must demonstrate bioequivalence to the brand name drug to be approved by the FDA. Bioequivalence means there is no significant difference in how fast or how much of the drug reaches the bloodstream. It is measured by comparing the rate (Cmax) and extent (AUC) of absorption between a generic and the brand name drug. Conducting in vivo studies is the most common way to establish bioequivalence, though in vitro dissolution testing or a biowaiver may also be granted under certain conditions. If bioequivalence is demonstrated, it confirms that generics are as safe and effective as their brand name counterparts.
Effetti a lungo termine dell'associazione a dose fissa di latanoprost e timol...Merqurio
This prospective study observed 2339 patients with glaucoma or ocular hypertension who were switched to latanoprost/timolol fixed combination therapy for at least 18 months. The primary reasons for switching were inadequate intraocular pressure (IOP) reduction and desire for once-daily dosing. IOP was effectively reduced and maintained over 24 months. Optic disc and visual field assessments showed stability. Physicians rated the fixed combination as effective, well-tolerated, and that patients were compliant with the treatment regimen.
The document discusses multidrug use in the elderly. It notes that the elderly population is growing and consuming more prescription drugs. Age-related changes to pharmacokinetics and pharmacodynamics can increase risks of adverse drug events from polypharmacy. Drugs are metabolized and cleared more slowly from the body due to reduced liver and kidney function. The elderly also experience increased drug sensitivity. Careful monitoring is needed to balance treatment benefits and risks.
The document discusses Signals' approach to drug repositioning using big data. It introduces Signals and their product intelligence expertise. Their solution automatically produces and delivers business analytics by collecting, integrating and analyzing big data from open web sources. The presentation discusses the challenges in drug development, need for repositioning, and Signals' evidence-based data model and methodology for characterizing a drug and generating queries to identify novel opportunities for increasing its ROI by detecting similar drugs, modifications, conditions and genomic data.
1) The document discusses preservative-free glaucoma medications like SAFLUTANTM (tafluprost) which may have benefits over preserved drops in reducing ocular surface damage and improving patient comfort and compliance.
2) SAFLUTANTM is a highly potent prostaglandin analogue that lowers intraocular pressure effectively in studies while being associated with fewer adverse symptoms than latanoprost.
3) Long-term studies show SAFLUTANTM maintains intraocular pressure control comparable to latanoprost over 24 months with a safety profile comparable to latanoprost.
Top 10 Biotech Companies & Market Share 2008Sheetal Narkar
The document analyzes the biotech market in 2007-2008 and summarizes the top 10 biotech companies by sales. Amgen was the top company with $15.9 billion in sales, mainly from blockbuster drugs like Enbrel, Neulasta, and Neupogen. Roche/Genentech was second with $15.4 billion from drugs like Rituxan, Herceptin, and Avastin. The document outlines each company's current blockbuster drugs and promising new treatments in their pipelines.
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
This was a lecture in the course "Significant Medical Conditions in Seniors" presented at Peer Learning in Chapel Hill, NC, USA in 2016 by Michael C. Joseph, MD, MPH.
Clinical and Pharmacoeconomic analysis was extensivley done on Eylea for its placement on a hypothetical health plans formulary for Macular Degeneration. Information was presented to a panel of pharmacy professionals in managed care and industry
The document discusses generic drugs and biosimilars. It provides biographical information about the speaker and outlines key questions about generics that will be addressed. Generic drugs are defined as comparable but not identical to brand name drugs in dosage, strength, quality and performance. Biosimilars are similar to biologic drugs but require more extensive testing than generics due to their complex nature. The market for generic drugs is large and growing, particularly in emerging markets, as major drugs lose patent protection.
This document provides background information on counterfeit and substandard drugs, with a focus on paracetamol tablets sold in Nigeria. It discusses how counterfeit drugs are prevalent worldwide, especially in developing countries, and the health risks they pose. In Nigeria, the National Agency for Food and Drug Administration and Control regulates drugs and has taken steps to curb counterfeits. The document then outlines the aims of analyzing different brands of paracetamol tablets sold in Lagos to evaluate their potency and efficacy. Various quality tests are described, including appearance, weight, hardness, and dissolution rate.
A Study On The Portfolio O Drugs Recommended For Neurologial DisordersSaumya Agarwal (Sam)
The document summarizes a study on recommended drug portfolios for various neurological disorders. Key findings include:
- The study analyzed the preferred drug choices of 41 doctors in Hyderabad for diseases like epilepsy, Alzheimer's, psychosis, migraine, insomnia, depression and Parkinsonism.
- The proposed drug portfolio for each disease is based on the preferred molecules identified from the doctors' responses. For example, the portfolio for epilepsy includes Divalproex, Clobazam, Oxcarbazepine, Levetiracetam, Lamotrigine and Clobazam.
- Reasons for switching prescriptions between molecules/brands included severity of disease, adverse drug reactions, patient response
A Study On The Portfolio O Drugs Recommended For Neurologial DisordersSaumya Agarwal (Sam)
The document summarizes a study on recommended drug portfolios for various neurological disorders. Key findings include:
- The study analyzed the preferred drug choices of 41 doctors in Hyderabad, India for diseases like epilepsy, Alzheimer's, psychosis, migraine, insomnia, depression and Parkinsonism.
- The proposed drug portfolio for each disease is based on the preferred molecules identified from the doctors' responses. For example, the portfolio for epilepsy includes Divalproex, Clobazam, Oxcarbazepine, Levetiracetam, Lamotrigine and Clobazam.
- Reasons for switching prescriptions between molecules/brands included severity of disease, adverse drug reactions,
April 2009 Community Call
When integrated medication processes and automated cabinets are in place, pharmacists are enabled to practice more “clinical pharmacy”. Often this means getting pharmacists out of the basement and onto the floors where they are available to patients and their caregivers. One of pharmacy’s services is to promote a safe, effective, and economical list of preferred drugs. With well-designed EHR technology as a tool, pharmacists can proactively influence physicians to choose the “right” drug. They can also measure and report on compliance to formulary preferences. The goal of this session is to explore the options available and present experience with a program currently in place at one of our ecosystem sites.
This topic is both clinical and administrative in nature and will likely be useful to all pharmacy staff, clinical specialists involved in building/maintaining CPOE systems, physicians, nurses and others interested in pharmacy management, both from a clinical and fiscal perspective.
Please feel free to forward this invitation to any colleagues or associates who you believe would find this topic of interest or would like to participate in the discussion.
What: Pharmacy-driven Clinical Transformation
- Strategic Drug Selection
- What is it?
- Why do it?
- How can it be done?
- How is it measured?
- Who has done it?
- Transformation Working Group Update
- Review of status
- Open Project Updates
- OpenVista/GT.M Integration
- CCD/CCR collaboration
- Medsphere.org: Tip of the month
When: April 23, 12:30 - 2pm Pacific
Where: Dial-in: (888) 346-3950 // Participant Code: 1302465
Web conference: http://www.medsphere.com/infinite/
===
The community calls are listed on the Medsphere.org event calendar (http://medsphere.org/community-events/) and we will update each month's call as the agenda is solidified.
Details and Recording here: http://medsphere.org/blogs/events/2009/04/23/community-call-april-2009
The document summarizes trends in research and development of generic drugs in the global pharmaceutical industry. It provides an overview of historical developments in generic drug maker PLIVA dating back to 1928, and its combination with Barr Group in 2006 to form a global generic pharmaceutical company. It also discusses trends in the generic drug market, strategies for differentiation, and key factors for success in generic drug research and development, emphasizing the importance of speed, intellectual property positioning, and internal API development capabilities.
This document summarizes recent advances in treating age-related macular degeneration (AMD). It discusses new drugs that aim to prevent retinal damage or slow AMD progression by inhibiting angiogenesis, inflammation, the complement pathway, oxidative stress, and retinal toxin accumulation. It also describes surgeries like maculoplasty and bionic eye implants, as well as rehabilitation techniques and low vision aids. Promising new drug classes discussed include anti-angiogenics, complement inhibitors, neurotrophic factors, and antioxidants.
Glaucoma is a group of eye diseases characterized by optic nerve damage often associated with elevated intraocular pressure (IOP). Risk factors include increased IOP, age, family history, race, and diabetes. Goals of treatment are to lower IOP, control IOP fluctuation over 24 hours, and preserve vision while balancing medication efficacy and side effects. Common glaucoma drug classes lower IOP by decreasing aqueous humor production or increasing outflow, and are dosed 1-3 times daily with possible side effects like redness, fatigue, and drowsiness. Plateau iris syndrome is when the iris remains occluded after iridotomy due to anteriorly positioned ciliary processes; argon laser peripheral iridoplasty
The document describes an in vitro bioequivalence study of Glimepiride using biorelevant media. The aim was to evaluate the dissolution rate of Glimepiride in different biorelevant media, compare the bioequivalence of local generic brands to an innovator brand, and predict the effect of food in the GI tract on dissolution. Dissolution studies were conducted in four biorelevant media with two tablets each of three brands. Results showed that dissolution was highest in the intestinal medium and reduced with food. Difference and similarity factors indicated the two generic brands were equivalent to the innovator brand. Using biorelevant media allowed prediction of dissolution rates and bioequivalence of the Glimepiride brands.
The biologic drug actemra® to dramatically increase the benefit of rheumatoid...Biosimilars
The document summarizes a study showing that the biologic drug Actemra is superior to Humira for rheumatoid arthritis patients receiving monotherapy treatment. The study found that after 24 weeks, patients receiving only Actemra showed greater improvement in reduced symptoms like joint swelling and inflammation compared to those receiving only Humira. These results provide physicians an improved treatment option for patients who cannot take methotrexate with their biological drug.
Generic drugs must demonstrate bioequivalence to the brand name drug to be approved by the FDA. Bioequivalence means there is no significant difference in how fast or how much of the drug reaches the bloodstream. It is measured by comparing the rate (Cmax) and extent (AUC) of absorption between a generic and the brand name drug. Conducting in vivo studies is the most common way to establish bioequivalence, though in vitro dissolution testing or a biowaiver may also be granted under certain conditions. If bioequivalence is demonstrated, it confirms that generics are as safe and effective as their brand name counterparts.
Effetti a lungo termine dell'associazione a dose fissa di latanoprost e timol...Merqurio
This prospective study observed 2339 patients with glaucoma or ocular hypertension who were switched to latanoprost/timolol fixed combination therapy for at least 18 months. The primary reasons for switching were inadequate intraocular pressure (IOP) reduction and desire for once-daily dosing. IOP was effectively reduced and maintained over 24 months. Optic disc and visual field assessments showed stability. Physicians rated the fixed combination as effective, well-tolerated, and that patients were compliant with the treatment regimen.
The document discusses multidrug use in the elderly. It notes that the elderly population is growing and consuming more prescription drugs. Age-related changes to pharmacokinetics and pharmacodynamics can increase risks of adverse drug events from polypharmacy. Drugs are metabolized and cleared more slowly from the body due to reduced liver and kidney function. The elderly also experience increased drug sensitivity. Careful monitoring is needed to balance treatment benefits and risks.
The document discusses Signals' approach to drug repositioning using big data. It introduces Signals and their product intelligence expertise. Their solution automatically produces and delivers business analytics by collecting, integrating and analyzing big data from open web sources. The presentation discusses the challenges in drug development, need for repositioning, and Signals' evidence-based data model and methodology for characterizing a drug and generating queries to identify novel opportunities for increasing its ROI by detecting similar drugs, modifications, conditions and genomic data.
1) The document discusses preservative-free glaucoma medications like SAFLUTANTM (tafluprost) which may have benefits over preserved drops in reducing ocular surface damage and improving patient comfort and compliance.
2) SAFLUTANTM is a highly potent prostaglandin analogue that lowers intraocular pressure effectively in studies while being associated with fewer adverse symptoms than latanoprost.
3) Long-term studies show SAFLUTANTM maintains intraocular pressure control comparable to latanoprost over 24 months with a safety profile comparable to latanoprost.
Top 10 Biotech Companies & Market Share 2008Sheetal Narkar
The document analyzes the biotech market in 2007-2008 and summarizes the top 10 biotech companies by sales. Amgen was the top company with $15.9 billion in sales, mainly from blockbuster drugs like Enbrel, Neulasta, and Neupogen. Roche/Genentech was second with $15.4 billion from drugs like Rituxan, Herceptin, and Avastin. The document outlines each company's current blockbuster drugs and promising new treatments in their pipelines.
Similar to Generic medication for glaucoma. pr. nordmann (20)
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
DECLARATION OF HELSINKI - History and principlesanaghabharat01
This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Kosmoderma Academy, a leading institution in the field of dermatology and aesthetics, offers comprehensive courses in cosmetology and trichology. Our specialized courses on PRP (Hair), DR+Growth Factor, GFC, and Qr678 are designed to equip practitioners with advanced skills and knowledge to excel in hair restoration and growth treatments.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Medical Quiz ( Online Quiz for API Meet 2024 ).pdf
Generic medication for glaucoma. pr. nordmann
1. Generic medication forGeneric medication for
glaucomaglaucoma
Pr. Jean-Philippe NordmannPr. Jean-Philippe Nordmann
University Paris V,University Paris V,
Hôpital des Quinze-VingtsHôpital des Quinze-Vingts
2. Pfizer
Xalatan
Xalacom
There is increasingly a choice of both branded andThere is increasingly a choice of both branded and
generic IOP-lowering drugsgeneric IOP-lowering drugs
EXCLUSIVITY EXPIRATION
Merck/Santen
Trusop
tCosop
t
Novartis
Azopt
Duotrav
Travatan
Azarga
Allergan
Ganfort
Lumigan 0.01%
3. France – Market share of Generic LatanoprostFrance – Market share of Generic Latanoprost
60%
5. What is the effect of generics inWhat is the effect of generics in
clinical practice?clinical practice?
Physicians
• Possibility of less
prescribing control
due to generic
substitution3,4
Third
parties
Patients
• Payers: potential for
cost-saving1
• Pharmacists: potential
for generic substitution
• Government
regulators: could
legislate that generics be
prescribed where
possible (as in France,
Spain2, …
)
1. Pechlivanoglou et al. BMC Health Serv Res 2011;11:89.
2. Rada. BMJ 2011;343:epub.
3. Lindstrom. Ocular Surgery News US edition 25 May 2011. Available from:
http://www.osnsupersite.com/view.aspx?rid=83789 .Accessed Jan 2012.
4. Holmes et al. Circulation 2011;124:1290–13104. 5. Greene. Lancet 2011;378:120−121.
• Change in a drug’s
appearance can
influence compliance5
6. Generics and brands:Generics and brands:
similar or identical?similar or identical?
Generics and brands:Generics and brands:
similar or identical?similar or identical?
7. Generic drugs: propertiesGeneric drugs: properties
1. Facts and myths about generic drugs. FDA. Available from: www.fda.gov .Accessed Jan 2012
2. EMEA Guideline on the Investigation of Bioequivalence, 2010. Available from:
www.ema.europa.eu Accessed Jan 2012
Generic drugs must
have the same
quality and
performance as the
brand name drugs1
Same active
ingredient, strength,
dosage form and
route of administration
as the branded drug1,2
Bioequivalence i.e.
blood levels similar to
those of reference
drug1,2
Properties of
systemic generics
However, inactive ingredients can differ
from the brand product e.g.
Preservatives, pH-adjusters,
antioxidants, buffers, thickening agents
8. How is bioequivalence of systemic genericsHow is bioequivalence of systemic generics
demonstrated?demonstrated?
A generic is consideredA generic is considered
bioequivalent to the brand if thebioequivalent to the brand if the
same levels of drug are shownsame levels of drug are shown
to be absorbed into theto be absorbed into the
bloodstreambloodstream
In other words, equivalentIn other words, equivalent
bioavailability must be shown, asbioavailability must be shown, as
assessed byassessed by
− Maximum blood concentration (CMaximum blood concentration (Cmaxmax))
− Time to reach maximum concentration (TTime to reach maximum concentration (Tmaxmax))
− Area under the curve (AUC)Area under the curve (AUC)
Drugconcentration(mg/mL)
Time after dose (h)
Cmax
Tmax
Brand
Generic
AUC
9. Non systemic generics:Non systemic generics:
Bioequivalence does not need to be shownBioequivalence does not need to be shown
For agents with local rather than systemic activityFor agents with local rather than systemic activity
(such as eye drops), bioavailability studies using(such as eye drops), bioavailability studies using
blood samples are difficult to performblood samples are difficult to perform11
Bioequivalence thus does not need to beBioequivalence thus does not need to be
demonstrated fordemonstrated for22
– GasesGases
– Ophthalmic products prepared as aqueous solutionsOphthalmic products prepared as aqueous solutions
– Topical products prepared as solutionsTopical products prepared as solutions
1. Cantor. J Glaucoma 1997;6:344–9.
2. EMEA Guideline on the Investigation of Bioequivalence, 2010. Available from: http://www.ema.europa.eu.
3. Vesga et al. Antimicrob. Agents Chemother 2010;54:3271–9.
Therapeutic equivalence is often assumed3
10. Is there therapeutic equivalence between brandedIs there therapeutic equivalence between branded
and generic ophthalmic agents?and generic ophthalmic agents?
• Some data show equivalence of brand toSome data show equivalence of brand to
genericgeneric
− A 6-week randomised, multicentre,A 6-week randomised, multicentre,
investigator-masked study of 266investigator-masked study of 266
patients with POAG or OH foundpatients with POAG or OH found
generic latanoprost was non-inferiorgeneric latanoprost was non-inferior
to Xalatan in IOP-lowering efficacyto Xalatan in IOP-lowering efficacy11
1. Allaire et al. Eur J Ophthalmol 2012;22:19–27.
-7.54 -7.29
-8
-7
-6
-5
-4
-3
-2
-1
0
Xalatan latanoprost
MeanIOPreduction(mmHg)at6weeks
p = ns
IOP reduction Xalatan vs generic latanoprost1
11. Is there therapeutic equivalence between brandedIs there therapeutic equivalence between branded
and generic ophthalmic agents?and generic ophthalmic agents?
• Some show differencesSome show differences
− A randomised, open-label,A randomised, open-label,
crossover study of 30 patientscrossover study of 30 patients
with glaucoma reported awith glaucoma reported a
significant difference in IOPsignificant difference in IOP
reduction between Xalatan and areduction between Xalatan and a
generic productgeneric product22
1. Narayanaswamy et al. Indian J Ophthalmol 2007;55:127–31.
Xalatan
IOP reduction of Xalatan vs generic latanoprost1
12. 88 years old Japanese patient88 years old Japanese patient
Switch from Xalatan (Pfizer)Switch from Xalatan (Pfizer)
to Latanoprost genericto Latanoprost generic
(Kaken Pharmaceutical)(Kaken Pharmaceutical)
Corneal ulceration appearingCorneal ulceration appearing
after each of the two attemptsafter each of the two attempts
to switchto switch
May be due to a surfactantMay be due to a surfactant
agent (Stearic Acid Polyester)agent (Stearic Acid Polyester)
Takada Y, Okada Y, Fujita N, Saita S. A Patient with corneal epithelial disorder that developped after administration of aY, Okada Y, Fujita N, Saita S. A Patient with corneal epithelial disorder that developped after administration of a
latanoprost generic, but not a brand-name drug eye drop. Case Rep Ophthalmol Med, 2012, 536746.latanoprost generic, but not a brand-name drug eye drop. Case Rep Ophthalmol Med, 2012, 536746.
13. Composition differences in genericsComposition differences in generics
• A study compared concentration of active
ingredients in brand vs generic glaucoma
medications
• Mean concentration of active ingredient in the
brand (Xalatan) was unchanged by increasing
temperature but was significantly reduced in the
generic versions (LT1 and LT2)
• Significantly higher levels of particulate matter
were found in the generic bottles vs brand
Kahook et al. Curr Eye Res 2011;epub
a
The summary of product characteristics for Xalatan states that the product should be stored in a refrigerator (2°C – 8°C)
and, once open, stored below 25°C and used within 4 weeks. http://www.medicines.org.uk
14. For Latanoprost generic : Yes!For Latanoprost generic : Yes!
For generic drugs before 1992: It depends!For generic drugs before 1992: It depends!
15. Current required policy for generic drugCurrent required policy for generic drug
Same active ingredientSame active ingredient andand
And the same inactive ones which are listed on theAnd the same inactive ones which are listed on the
package insertpackage insert
– In case of a solution, it is impossible to have differencesIn case of a solution, it is impossible to have differences
between productsbetween products
In consequence, no utility to conduct clinical trialsIn consequence, no utility to conduct clinical trials
– Better to evaluate the methodology to replicate theBetter to evaluate the methodology to replicate the
productproduct
– Variation of +/-10% is acceptableVariation of +/-10% is acceptable
16. Before 1992Before 1992
Inactive ingredients were not always identicalInactive ingredients were not always identical
May induce differences in efficacy and tolerabilityMay induce differences in efficacy and tolerability
In the US: brand-nameTimoptic XE vs genericIn the US: brand-nameTimoptic XE vs generic
– Drop size : 38Drop size : 38 µµl vs 24l vs 24 µµll
– Bottle tip : 3,5 vs 1Bottle tip : 3,5 vs 1
– Viscosity : 20 vs 1Viscosity : 20 vs 1
– Surface tension : 1,5 vs 1Surface tension : 1,5 vs 1
Mammo ZN, Flanagan JG, James DF, Trope GE. Generic versus brand-name North American topical glaucoma drops. Can J Ophthalmol, 2012,
47, 55-61.
17. Comments from patients with Latanoprost GenericComments from patients with Latanoprost Generic
« Does it have same efficacy? »« Does it have same efficacy? »
« I prefer the original brand for my eye »« I prefer the original brand for my eye »
Problem of packagingProblem of packaging
Problem of bottle quality (« squizzability »)Problem of bottle quality (« squizzability »)
Problem of color and shape of the bottleProblem of color and shape of the bottle
18. SummarySummary
As more IOP-lowering agents lose their patent, generics are likely
to occupy a greater space in the ophthalmology market
Non-systemic generics such as IOP-lowering eye drops do not
need to demonstrate bioequivalence to the brand
Evidence suggests that generics should not be considered identical
to brands due to differences in composition and, possibly, efficacy
Re-evaluation of IOP reduction when switching to generic drug
seems reasonable.
Editor's Notes
Generic substitution refers to switching between a branded drug and its therapeutically equivalent generic version ( Holmes et al. Circulation 2011;124:1290–1310).