Biosimilar Drugs
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•  Biological medicines contain active substances (substances that produce the desired therapeutic effect) that are
  produced by, or extracted from, living organisms. They are often made up of proteins that are naturally produced in the human body. When a biological medicine is given to a patient, it functions like the natural protein, resolving symptoms and preventing or slowing the progression of the disease.
• A biosimilar medicine is developed to be highly similar to a biological medicine that is already approved and available for patients, once the original patent has expired. The medicine that has already been approved is often called the ‘reference product’ or ‘originator product’.
• A biosimilar is a biologic product that is similar, but not identical, to a reference product, and therefore requires separate marketing approval upon patent expiration of the
  reference product
• Biosimilar or biosimilarity is defined in Section 351 of the PHS Act to mean that:
  1.“The biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components,” AND
  2.“There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product”.
• The bio similar product is expected to produce the same clinical result as the reference product in any given patient
• Large number of biological drug patents expire 2015 on wards
• Manufacture process is complex
  and expensive to achieve “similar” quality, safety, and efficacy profile
• There are about 150 biologics marketed worldwide and about 370 more are under development. Within the next 10 years (2009-2019) a total of 21 of these biologicals will lose their patent
• Biologics include a wide range of therapeutics, including recombinant hormones, growth factors, blood products, monoclonal antibody-based products, recombinant vaccines, and advanced technology products
• Biologics are among the most
  expensive drugs on the market, with average costs about 25 times that of no biologic drugs.

• About Biosimilar Medicine
• Basics
• FAQ
• Preparing for the Introduction
  of Biosimilars

Comparisons

• Biosimilars
• Biological and Biosimilar Medicines
• Biologic and Biosimilar Drugs - Guide to Buyers
• Differences between Biosimilars and small molecule generics

Patent Issues

• Patent Losses
• Patents Expiration
• Biosimilar Patenting
• Biosimilar Patent Litigation
• Patent Litigation Under a Future Biosimilars Act

Approval Pathways

• Regulatory Guidance - FDA
• Biosimilars – Regulation strategies and pathway
• Overview of the FDA approval pathway
• FDA’s first biosimilar approval
• Approval Process
• Evaluation
• USA Details
• FDA
• State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars

Opportunities

• Development of Biosimilar Drugs
• Opportunities for developers of biosimilars
• Opportunities in the USA Market

Economics

• The Economic Viability
• The Cost Savings Potential
• Cost Advantage
• Biologics Price Competition and Innovation Act of 2009

Clinical Trials

• Regulatory and Clinical Considerations
• The drugs entering the clinical trials
• Similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues
• Clinical comparability and European
  biosimilar regulations

Company profiles

• Company - India
• Company Annual Report
• Management & Financial Report
• Company Presentation
• Biologics & biopharmaceutical companies - Links
• List of Companies

Consultancy

• Report of Pharmaceuticals Consultant
• The strategy and transformation consulting
• Injectable Generic and Biosimilar Drugs

• Biosimilar Pharmaceuticals
• Global biosimilar development
• Trends in Bio similar Market - 2015
• Generics Industry Trends - 2015
• Future Outlook
• Commercial Strategies
• Perspective on the Evolving Biosimilars Landscape
• Competition in the USA
• Developments in the USA Market
• Problems & Prospects
• The Indian pharmaceutical Industry
• The Association of the British Pharmaceutical Industry

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