Definition of biopharmaceuticals and biosimilars, Steps involved in manufacturing biopharmaceuticals, Points of differences between Biosimilars and Chemical Generics, Related issues with biosimilars
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
An introductory presentation (ppt) on biosimilars and guidelines related to their approval along with the challenges faced by biosimilar industries in India.
United State Pharmacopoeia (USP)The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA) definitionIVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
Environmental Consequences of Genetically-Modified Foods, Biopharming and rBGHJack Olmsted
Martin Donohoe, MD, FACP
Portland State University
Oregon Physicians for Social Responsibility
With thanks to Rick North, Project Director, Campaign for Safe Food
Oregon Physicians for Social Responsibility
Definition of biopharmaceuticals and biosimilars, Steps involved in manufacturing biopharmaceuticals, Points of differences between Biosimilars and Chemical Generics, Related issues with biosimilars
Introduction, Regulatory requirements for validation, Role of FDA, Code of Federal regulation, Validation life cycle, Significance of validation, Types of validation, Process valiadation, Phases of process validation, Process capability design, Process Qualification, Validation maintainance phase
Types of Process validation, Examples
An introductory presentation (ppt) on biosimilars and guidelines related to their approval along with the challenges faced by biosimilar industries in India.
United State Pharmacopoeia (USP)The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form.
Food and Drug Administration (FDA) definitionIVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
Environmental Consequences of Genetically-Modified Foods, Biopharming and rBGHJack Olmsted
Martin Donohoe, MD, FACP
Portland State University
Oregon Physicians for Social Responsibility
With thanks to Rick North, Project Director, Campaign for Safe Food
Oregon Physicians for Social Responsibility
The present slide focuses on the applications and different uses of biosimilars along with the basic difference in between biosimilars and bioequivalence.
Global cancer biosimilars market opportunity outlookKuicK Research
"Global Cancer Biosimilars Market Opportunity Outlook" Report Highlight & Findings:
Introduction & Mechanism of Cancer Biosimilars
Global Cancer Biosimilars Market Dynamics
FDA & EMA Guidelines on Development & Marketing of Biosimilars
Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase
Cancer Biosimilars Clinical Pipeline: 100 Biosimilars
Marketed Cancer Biosimilars Clinical Insight
Marketed Cancer Biosimilars: 15 Biosimilars
Global cancer biosimilars market opportunity outlookKuicK Research
"Global Cancer Biosimilars Market Opportunity Outlook" Report Highlight & Findings:
Introduction & Mechanism of Cancer Biosimilars
Global Cancer Biosimilars Market Dynamics
FDA & EMA Guidelines on Development & Marketing of Biosimilars
Cancer Biosimilars Clinical Pipeline by Company, Indication & Phase
Cancer Biosimilars Clinical Pipeline: 100 Biosimilars
Marketed Cancer Biosimilars Clinical Insight
Marketed Cancer Biosimilars: 15 Biosimilars
Gino Martini, EIPG President
Presentation at Malta Qualified Persons Association-European Industrial Pharmacists Group-University of Malta joint seminar “The Successes And Challenges Of Today’s Pharmaceutical Industry”, Malta 2008.
Pharmacovigilance Risk Management for BiosimilarsCovance
This paper focuses on pharmacovigilance (PV) and risk management for biosimilars, the issues and challenges faced in monitoring their safety and possible solutions.
Demand for biologics will exceed $100 billion in 2015, experiencing continuing strong growth following a decade of double-digit annual increases. Continued growth will be driven by dramatic shifts in production technology and expansion of targeted diseases, and challenged by the introduction of biosimilar products following patent expiry of major biologic products.
Us biosimilars market opportunity & clinical pipeline analysisRajesh Sarma
“US Biosimilars Market Opportunity & Clinical Pipeline Analysis” Report Highlight:
US Biosimilars Market Introduction
US Biosimilars Regulatory Scenario
Unique Features of US Biosimilars Market
Impact of Biosimilars in US Market
Impact of Reimbursement Policies on US Biosimilars Market
Zarxio: First Approved Biosimilar in US
US Biosimilar Clinical Pipeline By Company, Indication & Phase
US Biosimilar Clinical Pipeline: 104 Biosimilars
Marketed Biosimilars: 1 Biosimilar
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Phyto-Pharmacological Screening, New Strategies for evaluating
Natural Products, In vitro evaluation techniques for Antioxidants, Antimicrobial and Anticancer drugs. In vivo evaluation techniques
for Anti-inflammatory, Antiulcer, Anticancer, Wound healing, Antidiabetic, Hepatoprotective, Cardio protective, Diuretics and
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This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
2. BiopharmaceuticalsBiopharmaceuticals
Biopharmaceuticals can be termed as medicalBiopharmaceuticals can be termed as medical
drugs made through biotechnology.drugs made through biotechnology.
These are therapeutic or preventive medicinesThese are therapeutic or preventive medicines
derived from cells using rderived from cells using r--DNA technology.DNA technology.derived from cells using rderived from cells using r--DNA technology.DNA technology.
First such substance approved for therapeuticFirst such substance approved for therapeutic
use was biosyntheticuse was biosynthetic Human insulinHuman insulin made bymade by
rDNA technology.rDNA technology.
3. The distinct families ofThe distinct families of
Biopharmaceuticals includes:Biopharmaceuticals includes:
Hormones and enzymesHormones and enzymes
Cytokines and peptideCytokines and peptide
VaccinesVaccines
Monoclonal AntibodiesMonoclonal Antibodies
Antisense drugsAntisense drugs
Cell therapiesCell therapies
4. BiologicalsBiologicals Conventional DrugsConventional Drugs
Mol. SizeMol. Size 50005000--200,000 Daltons200,000 Daltons 1010--1000 Daltons1000 Daltons
Mol. StructureMol. Structure Exhibit complex spatialExhibit complex spatial
structures, which arestructures, which are
difficult to determinedifficult to determine
Simpler spatial structure, easilySimpler spatial structure, easily
determined thru analyticaldetermined thru analytical
tech.tech.
ComplexityComplexity Complex ingredientsComplex ingredients
(impurities, leachables,(impurities, leachables,
excipients, byexcipients, by--product etc)product etc)
Relatively pure componentsRelatively pure components
ClinicalClinical
BehaviourBehaviour
Complicated modes of actionComplicated modes of action Well understood mode of actionWell understood mode of action
ManufacturingManufacturing
ProcessProcess
Specific & ComplexSpecific & Complex
biological processbiological process
Chemical synthesisChemical synthesis
Batch to batchBatch to batch
variationvariation
No 2 batches will be entirelyNo 2 batches will be entirely
identicalidentical
Small to negligible variationsSmall to negligible variations
ManufacturingManufacturing
costcost
HighHigh Relatively lowRelatively low
5. Facts & FiguresFacts & Figures
In 2009, global revenues of Biologicals were aroundIn 2009, global revenues of Biologicals were around
$125 billion.$125 billion.
More than 200 biologicals are already in market.More than 200 biologicals are already in market.
25% of the pipeline drugs are Biologicals25% of the pipeline drugs are Biologicals
It is estimated, by 2014 out of top 10 drugs 7 would be ofIt is estimated, by 2014 out of top 10 drugs 7 would be of
biological in origin.biological in origin.
Biosimilars are going to be the next big thing in globalBiosimilars are going to be the next big thing in global
medicinal industry.medicinal industry.
6.
7. Examples of genetically engineeredExamples of genetically engineered
recombinant proteins used in Medicines:recombinant proteins used in Medicines:
Recombinant ProteinRecombinant Protein Clinical applicationClinical application
Growth HormoneGrowth Hormone Growth hormone deficiencyGrowth hormone deficiency
Insulin like growth factor 1 (IGFInsulin like growth factor 1 (IGF--1)1) Growth disorders resistant toGrowth disorders resistant to
growth hormonegrowth hormone
InsulinInsulin Diabetes MellitusDiabetes Mellitus
Follicle stimulating hormone (FSH)Follicle stimulating hormone (FSH) Ovulation InductionOvulation Induction
8. Top 20 biopharmaceutical drugsTop 20 biopharmaceutical drugs
Drug nameDrug name IndicationIndication Revenue (2008)Revenue (2008)
1. Enbrel (Amgen)1. Enbrel (Amgen) Rheumatoid arthritis, ++Rheumatoid arthritis, ++ $5,982 M$5,982 M
2. Rituxan (Genentech)2. Rituxan (Genentech) NonNon--Hodgkin’sHodgkin’s
lymphoma ++lymphoma ++
$5,082 M$5,082 M
3. Humira ( Abbott)3. Humira ( Abbott) Rheumatoid arthritis, ++Rheumatoid arthritis, ++ $4,521 M$4,521 M
4. Avastin (Genentech)4. Avastin (Genentech) Colorectal cancer ++Colorectal cancer ++ $4,479 M$4,479 M
5. Herceptin (Genentech5. Herceptin (Genentech Breast cancerBreast cancer $4,394 M$4,394 M
6. Remicade (J&J)6. Remicade (J&J) Crohn’s disease ++Crohn’s disease ++ $3,748 M$3,748 M
7. Gleevac (Novartis)7. Gleevac (Novartis) Chronic myelogenousChronic myelogenous
leukemia ++leukemia ++
$3,700 M$3,700 M
8. Neulasta (Amgen)8. Neulasta (Amgen) InfectionsInfections $3,318 M$3,318 M
9. Lantus (Sanofi aventis9. Lantus (Sanofi aventis Type I & II diabetesType I & II diabetes $3,159 M$3,159 M
10. Aranesp (Amgen)10. Aranesp (Amgen) AnemiaAnemia $3,137 M$3,137 M
13. BiosimilarsBiosimilars
Biosimilars are the equivalent of generics forBiosimilars are the equivalent of generics for
Biologicals.Biologicals.
It is estimated that $20 billion worth of biologics willIt is estimated that $20 billion worth of biologics will
come off patent by 2015come off patent by 2015
The global biosimilars market is expected to beThe global biosimilars market is expected to beThe global biosimilars market is expected to beThe global biosimilars market is expected to be
worth US$19.4 billion by 2014, growing at a CAGRworth US$19.4 billion by 2014, growing at a CAGR
of 89.1% from 2009 to 2014of 89.1% from 2009 to 2014
Biosimilars have potential to yield cost savings.Biosimilars have potential to yield cost savings.
Sandoz Omnitrope the first Biosimilar to reachSandoz Omnitrope the first Biosimilar to reach
patients.patients.
14. Difference between Small molecule Generics & BiosimilarsDifference between Small molecule Generics & Biosimilars
15. Market advantageMarket advantage
Blockbuster Biotech InnovatorBlockbuster Biotech Innovator
drugs to go off patent.drugs to go off patent.
Biosimilars will cost 20Biosimilars will cost 20--25%25%
lesser than that of parentlesser than that of parentlesser than that of parentlesser than that of parent
biologics, which are amongstbiologics, which are amongst
the most expensive medicines.the most expensive medicines.
Annual consumer expenditureAnnual consumer expenditure
for biologics has grown by 12for biologics has grown by 12––
15%15%
16. 300
400
500
600
700
800
900
1
2
3
4
Global Markets for Biosimilars by type ($ US million)
0
100
200
300
2008 2009
4
1= Recombinant Non-glycosylated protein (Interferons, HGH, GCSF, Insulin, Interleukin)
2= Peptides (Glucagon, LH-RH, Calcitonin, Cyclosporine)
3= Recombinant glycosylated preotien (EPO, Mabs) Follitropin, Thyrotropin, DNase)
4= Others
17. Global Markets for Biosimilars by disease ($ US Million)Global Markets for Biosimilars by disease ($ US Million)
200
300
400
500
600
700
800
900
1
2
3
4
5
0
100
200
2008 2009
5
•1= Hematology
•2= Chronic & Autoimmune disease
•3= Growth related deficiencies
•4= Oncology
•5= Infectious & other diseases
18. Regulatory statusRegulatory status
Owning to the complex natureOwning to the complex nature
of Biologicals, strict testings areof Biologicals, strict testings are
to be there.to be there.
Pathway for approval in US isPathway for approval in US isPathway for approval in US isPathway for approval in US is
still evolving.still evolving.
Europe and Asia are theEurope and Asia are the
forerunners in Biosimilars.forerunners in Biosimilars.
India, China key players inIndia, China key players in
upcoming Biosimilars market.upcoming Biosimilars market.
19.
20. BIOSIMILARS : On the Brink of Accelerated Growth
Prediction of biosimilar sales by product in seven major markets (France, Japan, Germany, Italy, Spain, UK and US)
during 2008-2019.
Sources-IMS, Datamonitor
21. Biosimilars in INDIABiosimilars in INDIA
Dr. Reddy's and Biocon both brought biosimilar versionsDr. Reddy's and Biocon both brought biosimilar versions
of Roche's (Basel) Rituximab to market.of Roche's (Basel) Rituximab to market.
Zenotech LaboratoriesZenotech Laboratories-- developing at least six biosimilardeveloping at least six biosimilar
versions of mAbs.versions of mAbs.
Including Rituximab (which is ready to enter Phase III)Including Rituximab (which is ready to enter Phase III)
and Herceptin (trastuzumab)and Herceptin (trastuzumab)
Wockhardt have launched their EPO & Insulin.Wockhardt have launched their EPO & Insulin.
Reliance life sciences has launched 3 biosimilarsReliance life sciences has launched 3 biosimilars
Relipoeitin, Religrast & Reliferon in domestic market inRelipoeitin, Religrast & Reliferon in domestic market in
2008.2008.
22.
23. Key Players in IndiaKey Players in India
Dr. ReddysDr. Reddys
BioconBiocon
Intas BiopharmaceuticalsIntas Biopharmaceuticals
Ranbaxy laboratoriesRanbaxy laboratoriesRanbaxy laboratoriesRanbaxy laboratories
GlenmarkGlenmark
Reliance Life sciencesReliance Life sciences
BiologicalBiological--EE
WockhardtWockhardt