Biosimilar current market and its future scope
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This document provides an overview of biosimilars including what they are, approval requirements, differences from generics, major companies involved, current and future market sizes with a focus on Europe which currently dominates the global biosimilar market. Key applications discussed are oncology, blood disorders, and autoimmune diseases. Recent advances and growth in Asia-Pacific region are also mentioned.
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The pharmaceutical industry
The document discusses the history and development of the pharmaceutical industry from the mid-20th century onward. It describes how antibiotics and vaccines helped eradicate diseases and increase life expectancy. It outlines the FDA drug approval process and the four phases of clinical trials drugs must go through to demonstrate safety and efficacy. Finally, it considers ongoing challenges like high drug prices but predicts the industry will continue innovating to meet medical needs.
Biologics market
The Biologics Market was worth USD 267.58 billion in 2014 and is expected to reach approximately USD 373.66 billion by 2023, while registering itself at a compound annual growth rate (CAGR) of 3.78% during the forecast period. Biologics are medicates as hereditarily built proteins, got from human qualities. According to the US FDA, biologics can be made out of sugars, proteins, or nucleic acids or complex blends of these substances, or might live elements, for example, cells and tissues. The biologic medications are taken from an assortment of regular sources, for example, people, creatures, or microorganisms and comprise of items, for example, antibodies, blood and blood parts, allergenic, substantial cells, quality treatment, tissues, and recombinant remedial proteins. Propelled biotechnology strategies and complex procedures are utilized to produce biologics. They are at the cutting edge of biomedical research.
Biosimilars-emerging market in india
Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
How dissimilarly similar are biosimilars
This document discusses biosimilars, which are biologic medications that are similar but not identical to an original biologic reference medication. It provides background on biosimilars and regulatory guidelines around them. Specifically, it notes that biosimilars take 6-9 years to develop compared to 3 years for generics, and that they require clinical trials to demonstrate safety and efficacy compared to the reference medication. The document also discusses biosimilar guidelines in India and examples of biosimilars used in cancer treatment, noting some differences between biosimilar versions of medications like G-CSF and interferons.
pharmaceutical industry
Pharmaceutical industry
Overview of industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications.
Pharmaceutical companies may deal in generic or brand medications and medical devices.
Global Players of Industry
Johnson & Johnson
With nearly US$71.89 billion more in revenue, Johnson & Johnson is by far the world’s largest pharmaceutical company based on revenue.
Pfizer (US$52.82bn)
In second place, American biopharmaceutical company Pfizer has moved up two places from last year. The company focuses on a wide range of therapy areas including oncology, neuroscience, metabolic diseases and rare disease, as well as developing vaccines.
Roche (US$50.11bn)
In the top three pharmaceutical companies of 2017 is another Swiss-based pharma, Roche. The company develops drugs and diagnostic instruments and has a presence in Europe, North America, South America and Asia.
Bio similar- An opportunities or challenge for Indian Company
1. The global biosimilars market is expected to grow significantly in the coming years due to various drivers such as patent expiries of major biologics and increasing cost containment pressures.
2. Indian companies are well positioned in the biosimilars space due to their established low-cost manufacturing capabilities and expertise in biologics. Key players in India include Dr. Reddy's, Biocon, Cipla and Intas.
3. Developing biosimilars presents several challenges including high development costs, complex clinical trials and unclear regulatory guidelines. Indian companies strategy involves partnerships for cost-effective development and leveraging domestic capabilities and emerging markets for growth.
Biosimilar - a mAb case study
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.
U.S. Regulation of Biosimilars
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•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
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Biologics market
The Biologics Market was worth USD 267.58 billion in 2014 and is expected to reach approximately USD 373.66 billion by 2023, while registering itself at a compound annual growth rate (CAGR) of 3.78% during the forecast period. Biologics are medicates as hereditarily built proteins, got from human qualities. According to the US FDA, biologics can be made out of sugars, proteins, or nucleic acids or complex blends of these substances, or might live elements, for example, cells and tissues. The biologic medications are taken from an assortment of regular sources, for example, people, creatures, or microorganisms and comprise of items, for example, antibodies, blood and blood parts, allergenic, substantial cells, quality treatment, tissues, and recombinant remedial proteins. Propelled biotechnology strategies and complex procedures are utilized to produce biologics. They are at the cutting edge of biomedical research.
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Hi all, with the rigorous secondary research for almost one month helped me to understand basic things about biosimilars and made me do this presentation. Hope u will appreciate it while going through it. thanks.
If anyone in need of this presentation, pls.put ur emial ID in comment box. will be sharing. and please share your thoughts about the presentation. i will be more thankful.
How dissimilarly similar are biosimilars
This document discusses biosimilars, which are biologic medications that are similar but not identical to an original biologic reference medication. It provides background on biosimilars and regulatory guidelines around them. Specifically, it notes that biosimilars take 6-9 years to develop compared to 3 years for generics, and that they require clinical trials to demonstrate safety and efficacy compared to the reference medication. The document also discusses biosimilar guidelines in India and examples of biosimilars used in cancer treatment, noting some differences between biosimilar versions of medications like G-CSF and interferons.
pharmaceutical industry
Pharmaceutical industry
Overview of industry
The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical drugs for use as medications.
Pharmaceutical companies may deal in generic or brand medications and medical devices.
Global Players of Industry
Johnson & Johnson
With nearly US$71.89 billion more in revenue, Johnson & Johnson is by far the world’s largest pharmaceutical company based on revenue.
Pfizer (US$52.82bn)
In second place, American biopharmaceutical company Pfizer has moved up two places from last year. The company focuses on a wide range of therapy areas including oncology, neuroscience, metabolic diseases and rare disease, as well as developing vaccines.
Roche (US$50.11bn)
In the top three pharmaceutical companies of 2017 is another Swiss-based pharma, Roche. The company develops drugs and diagnostic instruments and has a presence in Europe, North America, South America and Asia.
Bio similar- An opportunities or challenge for Indian Company
1. The global biosimilars market is expected to grow significantly in the coming years due to various drivers such as patent expiries of major biologics and increasing cost containment pressures.
2. Indian companies are well positioned in the biosimilars space due to their established low-cost manufacturing capabilities and expertise in biologics. Key players in India include Dr. Reddy's, Biocon, Cipla and Intas.
3. Developing biosimilars presents several challenges including high development costs, complex clinical trials and unclear regulatory guidelines. Indian companies strategy involves partnerships for cost-effective development and leveraging domestic capabilities and emerging markets for growth.
Biosimilar - a mAb case study
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.
U.S. Regulation of Biosimilars
Presentation at the Biosimilars and Follow-On Biologics 2014 Americas Conference, sponsored by Paradigm Global Events, February 12, 2014. Presentation focused on:
•Interchangeability
•State Substitution Laws
•Naming
•Risk Evaluation & Mitigation Strategies (REMS) and Their Impact on Biosimilars
•Where FDA Stands on Biosimilars
New drug approvals & upcoming fda approvals 2021
In the first half of 2021, the U.S. FDA approved a total of 29 innovative drugs, of which 27 were new molecular entities and new biologics approved by the Center for Drug Evaluation and Research (CDER) and the remaining two were Car-T therapies (Abecma and Breyanzi) approved by the Center for Biologics Evaluation and Research (CBER).
Pharmaceutical industry
The India Pharmaceutical Industry is developing, producing and marketing drugs.
The pharmaceutical companies are generally dealing in generic or brand medications and medical device.
Indian Pharmaceutical Industry today is in the front rank of India’s science-based industries with wide ranging capabilities in the complex field of drug manufacture and technology.
India enjoys a important position in the global pharmaceutical market. The Indian pharmaceuticals market is the third largest in terms of volume and thirteenth largest in terms of value.
It ranks very high in the third world, in terms of technology, quality and range of medicines manufactured.
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Market Overview
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Biosimilars Pipeline: 276 in Development Phase
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How the biologics landscape is evolving
1) As biologic drug sales increase, manufacturers are developing biosimilars and biobetters to maximize returns and benefit patients. Biosimilars may lower costs through competition, while biobetters aim to improve existing drugs.
2) Biosimilars are not identical to original biologics due to complex manufacturing processes, but can be approved through clinical trials demonstrating similarity. Biosimilars may save 10-35% of originator costs in Europe.
3) The US represents a major market opportunity but has not approved a regulatory pathway. Widespread biosimilar use depends on generating physician and patient confidence in quality and safety.
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Especialista en Derecho Administrativo Económico
Especialista en Derecho Público, Ciencias y Sociología Políticas
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Carta de San Pablo a los Gálatas, Capítulo 5, Versículo 22.
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Asesoría y consultoría jurídica en reclamaciones económicas derivadas de los contratos, indemnizaciones patrimoniales del derecho de daños, responsabilidad contractual extracontractual, civil y del Estado, Asesorías en Derecho Patrimonial y reparación integral de daños resarcibles; Derecho Civil, Derecho Comercial, Derecho de Sociedades, Regulación, Derecho del Consumidor, y reclamaciones de siniestralidad en el Derecho de Seguros; AsesoríTaller final imagenes comentadas
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Biosimilar current market and its future scope
- 1. Biosimilar currentmarketanditsfuturescope By GopalAgrawal Departmentof Biotechnology NIPER-MOHALI
- 2. CONTENT • What is Biosimilar??? • Biosimilars approval requirement • BiosimilarVersus Generics • Indian company in Biosimilar • World Company in biosimilar • Recent Advances in Biosimilars • Current Market of Biosimilars • Future Scope of Biosimilars • References • Author information
- 3. highly similar to an already FDA-approved biological product have been shown to have no clinically meaningful differences
- 5. Mechanism of action • Route of administration • Dosage form • Strength • As the reference product • *****Biosimilars can only be approved for the conditions of use and indication for which the reference of the product is approved.
- 6. • The PHS Act requires that a 351(k) application include, among other things, information demonstrating biosimilarity based upon data derived from: • Analytical studies demonstrating that the biological product is “highly similar” to the reference product notwithstanding minor differences in clinically inactive components; • Animal studies(including the assessment of toxicity); and • A clinical study or studies(including the assessment of immunogenicity and pharmacokinetics (PK) or pharmacodynamics (PD)) that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the reference product is licensed and for which licensure is sought for the biosimilar product. • FDA may determine, in its discretion, that an element described above is unnecessary in a 351(k) application.
- 7. • Comparative human PK (and PD) data • PK and/or PD is generally considered the most sensitive clinical study/assay in which to assess for differences, should they exist Support a demonstration of biosimilarity with the assumption that similar exposure (and pharmacodynamic response) provides similar efficacy and safety (i.e., an exposure-response relationship exists) Clinical PK data generally will be expected; PD data desirable (case by case consideration)
- 8. • Study Design Study population PD endpoint Route of administration • Data analysis plan Acceptance range Choice of primary endpoints Others
- 12. • On the basis of applications the biosimilars market is segmented into oncology, blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, and other applications (female infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, and chronic kidney failure). Oncology accounts for the largest share of the global market, owing to the launch of new biosimilars, namely, Remsima (monoclonal antibody) in Europe, and Neutroval and tbo-filgrastim in the U.S. • The high growth in this segment can be attributed to the rising incidences of autoimmune disorders such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis,Type 1 diabetes, and psoriasis.
- 13. • Geography, the biosimilars market is segmented into North America, Europe, Asia-Pacific, and the RoW (Latin America, Middle East, and Africa). In 2015, Europe is expected to dominate the global market; growth in this market can be attributed to the growing pressure to curtail healthcare costs, patent expiry of biologic products, launch of new biosimilar products, rising incidences of chronic disorders (such as cancer, diabetes, and rheumatoid arthritis), and emergence of new market participants in this region.
- 16. Sandoz International GmbH (Germany) Hospira, Inc. (U.S.) Teva Pharmaceutical Industries Ltd. (Israel) Dr. Reddy’s Laboratories (India) Biocon Limited (India) Mylan, Inc. (U.S.) Amgen (U.S.) Celltrion Inc. (South Korea) Roche Diagnostics (Switzerland) Merck KGaA (Germany).
- 17. • Europe Currently, there are three biosimilar versions of G-CSF available in the European market, namely Ratiograstim/Tevagrastim/Biograstim, Zarzio/Filgrastim Hexal and Nivestim/Pliva/Mayne filgrastim
- 18. the recombinant nonglycosylated protein segment is expected to account for the largest share of the biosimilars market in 2015 the global biosimilars market is dominated by Europe the Asia-Pacific region is likely to witness the highest growth rate during the forecast period