Definition of biopharmaceuticals and biosimilars, Steps involved in manufacturing biopharmaceuticals, Points of differences between Biosimilars and Chemical Generics, Related issues with biosimilars
Definition of biopharmaceuticals and biosimilars, Steps involved in manufacturing biopharmaceuticals, Points of differences between Biosimilars and Chemical Generics, Related issues with biosimilars
This presentation mainly deals with clinical development of biosimilar products. It also gives enough on non-clinical development so that the audience is well oriented.
Biosimilars are biological generics drugs.They undergo a rigorous evaluation to get approved.How to prove biosimilariy from analytical comparability is explained using a recently approved US FDA bio-similar monoclonal antibody.
Bioavailability and Bioequivalence StudiesPranav Sopory
BA and BE studies.
Seminar presented in All India Institute of Medical Sciences (AIIMS - New Delhi).
Focus in Pharmacokinetic parameters (Cmax, AUC)
Single dose PK study, Steady state PK study, Modified drug release PK study, In vivo mechanisms, invitro mechanisms, Pharmacodynamic Study, Comparatice Clinical Trials. Biowavers and Biosimilimars.
Reference: CDSCO guideline, USFDA guideline, ICH guidelines
This presentation mainly deals with clinical development of biosimilar products. It also gives enough on non-clinical development so that the audience is well oriented.
Biosimilars are biological generics drugs.They undergo a rigorous evaluation to get approved.How to prove biosimilariy from analytical comparability is explained using a recently approved US FDA bio-similar monoclonal antibody.
Bioavailability and Bioequivalence StudiesPranav Sopory
BA and BE studies.
Seminar presented in All India Institute of Medical Sciences (AIIMS - New Delhi).
Focus in Pharmacokinetic parameters (Cmax, AUC)
Single dose PK study, Steady state PK study, Modified drug release PK study, In vivo mechanisms, invitro mechanisms, Pharmacodynamic Study, Comparatice Clinical Trials. Biowavers and Biosimilimars.
Reference: CDSCO guideline, USFDA guideline, ICH guidelines
The present slide focuses on the applications and different uses of biosimilars along with the basic difference in between biosimilars and bioequivalence.
Drug Types: Biosimilars, generics and more. December 2017 Webinar 12122017Fight Colorectal Cancer
Specialty pharmacist Stevan Lalich of CVS Health breaks down the differences between biosimilar, biologic, generic, and brand name drugs – and why it’s important! In this comprehensive webinar, learn about the medicines in your cabinet and the process they endure before reaching you. This is a timely and unique webinar not to be missed
Biosimilars, a pharmacist’s perspectiveBiosimilars
Not many things can profoundly affect and perhaps even alter a profession, let alone the pharmacist’s profession. However, biosimilars might do just that.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
2. INDEX
Introduction to biopharmaceuticals
What are biologics?
What are biosimilars?
Indian scenario
Difference between biologics and generics
Concerns with biosimilars
Who regulatory guidelines for biosimilars
Indian regulatory guidelines
Conclusion
3. Introduction
For many years, the pharmaceutical
industry traditionally developed
chemical drugs (also referred to as
small molecules), including well-
known medicines such as
acetylsalicylic acid, to treat a wide
range of illnesses.
Since the 1970’s a revolution in
Biotechnology resulted in New class
of medicine: The Biologics
4. What are Biologic Medicines ?
• A large Protein molecule typically derived from living cells
and used in the treatment or prevention of disease
• Include therapeutic proteins, DNA, monoclonal antibodies
and fusion proteins.
• Often 200 to 1,000 times the size of a small molecule drug
and far more complex structurally.
Examples :
Human Growth hormone
Human insulin
Erythropoietin
Vaccines
Monoclonal antibodies
7. What are biosimilars?
• Legally approved subsequent versions
of innovator biopharmaceutical
products made by a different sponsor
following patent & exclusivity expiry
of the innovator product.
• Because of structural &
manufacturing complexities, these
biological products are considered as
similar, but not generic equivalents of
innovator biopharmaceuticals
8. DEFINITION OF BIOSIMILARS
SBP (Similar Biologic
Product)
A biotherapeutic product
which is similar in terms of
quality, safety and efficacy
to an already licensed
reference biotherapeutic
product
FOB (Follow-On Biologic)
A biological product that is
highly similar to a U.S. licensed
reference biological product
with no clinically meaningful
differences in terms of the
safety, purity and potency .
9. Based on these different definitions,
Three determinants in definition of
biosimilar product:
1. It should be a biologic product
2. Reference product should be an already licensed
biologic product
3. Demonstration of high similarity in safety, quality &
efficacy is necessary
Similarity should be demonstrated using a set of
comprehensive comparability exercises at the quality,
non-clinical & clinical level
10. Biosimilars
Unlike generic medicines where the active ingredients are
identical, biosimilars – by definition are not likely to be
identical to the originator biologic.
Similar to Snowflakes Biologics made by different
manufacturers differ from the original product and from each
other.
11.
12. The Structure of Monoclonal Ab’s
• Therapeutic mAb’s
predominantly of Ig G1 class &
subtypes.
• Ig G consists of 2 Heavy and
light chains
• Around 150 kDa in Size.
• Chains held together by
disulfide bond between
conserved cysteine residues
at the Hinge region.
• Fc region binding cell surface
Ig receptor
• Antigen binding variable
region.
13. Classes of Biologicals
- “Biologic”s is a generic term used to refer to
numerous types of peptide and protein based
therapeutic molecules.
- Biologicals themselves can differ significantly in
size and complexity.
- Examples:
Small peptides: Insulin, Fuzen
Medium proteins: Epogen, Neupogen.
Large Proteins: Herceptin, Avastin.
Increasing size and
complexity
14.
15.
16.
17. Therapeutic effects of BRMs.
1. Regulation and/or increased immune
response.
2. Cytotoxic or cytostatic activity against tumor
cells.
3. Inhibition of metastasis, or cell maturation.
4. Stimulation of BM stem cells, required for
recuperation from cytotoxic insult secondary to
chemotherapy.
18. Production of biologic
• The genetic code of a chosen protein, such as
immune system antibody is identified and
replicated by combining different segments of
DNA to build a functional DNA sequence
• This DNA sequence is introduced into the host
cell of a living organism, such as mammal cells
altering the cell to produce the chosen protein.
• These genetically modified cell lines are
carefully selected (MASTER CELL LINE) and
cultured in large bioreactors before the
biologic medicine is extracted through complex
and lengthy purification process
19.
20. Key challenges of biosimilar monoclonal Ab
development
Correct amino acid sequence
Similar Glycoform structure
Comparable pre-clinical activity
High-yield master cell bank/working cell bank
Scalable manufacturing process
21. Differences between chemical generics
& biosimilars
1. Heavier
Unlike structurally well-defined, low molecular weight
chemical drugs, biopharmaceuticals are:
High molecular weight compounds with complex
three-dimensional structure
For example, the molecular weight of Aspirin is 180 Da
whereas Interferon-β is 19,000 Da
22. 2. Larger
Typical biologic drug is 100 to
1000 times larger than small
molecule chemical drugs.
Possesses fragile three-
dimensional structure as
compared to well-
characterized one-dimensional
structure of chemical drug.
23. 3. Difficult to define structure
Small Molecule drugs → easy
to reproduce & specify by
mass spectroscopy & other
techniques.
Lack of appropriate
investigative tools to define
composite structure of large
proteins
24. 4. Complex manufacturing processes
Manufacturers of biosimilar products will
not have access to manufacturing process
of innovator products→ Proprietary
knowledge
Impossible to accurately duplicate any
protein product
Different manufacturing processes use
different cell lines, protein sources &
extraction & purification techniques→
heterogeneity of biopharmaceuticals
25. continued
• Versatile cell lines used to produce the proteins
have an impact on the gross structure of the
protein
• Such alterations may significantly impact:
Receptor binding, Stability, Pharmacokinetics &
Safety
• Immunogenic potential of therapeutic proteins→
Unique safety issue→ Not observed with
chemical generics
26. Benefits of Biosimilars
“The development of biosimilars allows for wider
and, as important, earlier access to these agents
because of their lower cost and consequently greater
affordability”1
“lower cost is expected not only to improve cost-
efficacy ratios, but also to improve drug access, “2
27. Emerging Role of Biosimilars
Countries around the world- growing, aging
population ---> ↑ in chronic disease.
Expanding demand for good-quality
healthcare ---> challenge of controlling
healthcare expenditure.
The safe and regulated introduction of
biosimilars into the market has been
forecasted to increase access to much needed
biologic medicines and reduce costs.
28. Concerns with Biosimilars
The two biosimilar products have different origin.
The two biosimilars may have same therapeutic effect.
They may have different side effect and toxicology.
Hence Biosimilars require thorough testing.
• Similarity between a biosimilar and its reference
biotherapeutic product should be evaluated in all
respects (quality, safety and efficacy).
• Purported copies of biotherapeutic medicines that have
not undergone head-to-head comparisons with an
appropriate reference product put patient safety at risk
and should not be licensed via biosimilar pathways.
29. Issues of concern with use of biosimilars
1. Efficacy issues
Differences between the bioactivity of the biosimilars & their
innovator products
Example:
• 11 epoetin alfa products from 4 different countries (Korea,
Argentina, China, India)
• Significant diversions from specification for in vivo bioactivity
• Ranged from 71-226%
30. 2. Safety issues
Concerns regarding immunogenicity
Example:
↑ in no. of cases of Pure Red Cell Aplasia
associated with specific formulation of epoetin α
Caused by the production of neutralizing
antibodies against endogenous epoetin
31. 3. Pharmacovigilance
Due to limited clinical database at the time of
approval→ Vigorous pharmacovigilance required
Immunogenicity is a unique safety issue
Adverse drugs reactions monitoring data should
be exhaustive
Type of adverse event & data about drug such as:
Proprietary name, International nonproprietary
name (INN) & dosage
32. 4. Substitution
Allows dispensing of generic drugs in place of
prescribed IP
Rationale for generics→ Original drugs & their
generics are identical & have the same
therapeutic effect
Produce cost savings
33. Same substitution rules should not be
applied:
Decrease the safety of therapy or cause
therapeutic failure
Uncontrolled substitution → confounds accurate
pharmacovigilance
Adverse event emerges after switching from IP to
its biosimilar without documentation → event
will not be associated to a specific product or it
will be ascribed to a wrong product
34. Naming and labeling
Generic adaptation of chemical medicines is assigned the
same name→ identical copies of the reference products
Biosimilars require unique INNs, as this would facilitate:
Prescribing & dispensing of biopharmaceuticals:
Precise pharmacovigilance
Need for Comprehensive labeling of biosimilars including
deviations from IP & unique safety & efficacy data
Assist the physician & pharmacist in making informed
decisions
36. WHO regulations for Biosimilars
In 2009 the World Health Organization
developed a set of globally accepted
standards to assure the safety, efficacy
and quality of biosimilar medicines.
These have been developed in the wake
of increased interest in biosimilars by
local regulatory authorities seeking to
develop national standards.
37. What is biosimilarity ?
• “Biosimilarity” is the regulatory term used to denote
the comparability between a biosimilar and its
reference medicinal product.
• Regulatory bodies across the world including India,
recommends a stepwise approach to demonstrate
biosimilarity between a proposed medicine and the
original biologic
• The aim is to demonstrate no clinically meaningful
difference in terms of safety, potency and purity
39. Mostly Commonly used BRM’s in
Rheumatology
1. Infliximab: A monoclonal Ab to TNF, proinflammatory
cytokine.
Toxicity: Respiratory infection, fever, hypotension.
Predisposes to infections (reactivation of latent TB).
2. Rituximab: A monoclonal antibody to CD20 surface
immunoglobulin. Clinical use: Lymphoma.
3. Etanercept: Recombinant form of human TNF
receptor that binds TNF.
40. Ranbaxy lauched Indias first Biosimilar
of Infliximab – Infimab in Dec 01 2014
• Clinical effectiveness of
Infimab coupled with
cost effective pricing will
enable more number of
patients to get access to
biologic treatment in
india.
41. Etanercept - Etacept
• Cipla one of leading
pharmaceutical
company announced the
launch of first biosimilar
of etanercept in India,
known as etacept, in
Arpril 2013.
42.
43. Intas launched
biosimilar version of
Rituxumab – Mabtas in
India in April 2013 in
order to make
treatment of NHL cost
effective.
Rituxumab
44. limitations of patent Biologics
• Injection-site reactions are the most frequent adverse
events. The severity varies from mild redness to deep
inflammation and necrosis.
• In most cases, the treatment can be continued and the
severity of reactions will decrease with time.
• Like all foreign proteins, monoclonal antibodies may
induce urticaria, angioedema, anaphylactic reactions,
and serum sickness.
• Production of inactivating antibodies to the drug may
occur, classically with infliximab, and may be prevented
by concomitant administration of low-dose
methotrexate.
45. CONTINUED
• Alopecia is a common complication of IFN-α.
• A nonspecific, highly pruritic “dermatitis” is frequent in
patients receiving IFN and ribavirin for hepatitis C.
• Induction or exacerbation of various immune-mediated
disorders, especially lupus erythematosus, has been
reported with interleukin 2, IFN-α, and antitumor
necrosis factor α.
• Granulocyte colony-stimulating factor may induce
various neutrophil dermatoses, including Sweet’s
syndrome and pyoderma gangrenosum, and can
exacerbate psoriasis.
46. Indian scenario
Global market for Indian non-innovator
products-approximately USD 1.5 billion
per annum with annual growth rate of
27%.
Estimated exports of Indian biopharma
products increasing at rate of 47%
In India-good acceptance of non-
innovator products amongst health care
professionals and patients.
Several home-grown biopharma
industries now actively developing and
marketing non-innovator products in
India.
47. Summary
Biosimilars are highly similar versions of already
authorized innovator biological therapies
They demonstrate no clinically meaningful differences
vs their innovator products in terms of efficacy, safety,
quality characteristics, and biological activity
They must meet strict criteria of quality and
comparability to their respective innovator biologic
Biosimilars have demonstrated growing acceptance
and use
Biosimilars allow for wider and earlier access to
effective biologic therapies
48. Conclusion
With more and more innovator drugs going off patent,
urgent attention required to regulate increasing
number of copy biotherapeutics.
New non-innovator biotherapeutics should be made
available as soon as patent protection is over so that
economically compromised patients have an option to
opt for cheaper copy versions.
Reducing cost of drugs now a global priority rather
than just being a major issue in developing economies.