India As Biosimilar Development Hub

Release Date: 28-Aug-2012

Biosimilars have attracted huge investments in areas such as research, clinical trials and manufacturing. The sector provides several growth and investment opportunities for Indian and foreign players.Indiais one of the biggest sources of biosimilars and is also an emerging market for biosimilars with its high population and investment in technology. The Biosimilars market in India is driven by several factors including an increase in disease prevalence resulting from population growth, old age and unhealthy lifestyles, the need for broader access to medicines, increasing healthcare costs and the increasing demand for cheaper drugs, cost-effectiveness of biosimilars in comparison to their expensive counterparts, reduced risk of pipeline failure coupled with higher acceptability by patients, impending patent expiries of major biotechnology drugs, and the fast regulatory process for approval of biosimilars.

Launching biosimilar products in India also provides firms with an advantage to develop their post-marketing safety and efficacy data. This is specifically significant for biosimilar products as even minor changes in manufacturing processes may lead to serious health issues. One of the key challenges regarding biosimilar products is immunogenicity. Studies that compare innovator biologics and biosimilars often report differences in aggregate levels, protein concentration, stability, conformational states, and impurity profiles. Nevertheless, the biosimilar market is still nascent to gauge which of these differences is significant in determining the safety and efficacy impacts.

Biosimilar companies in India have a clear edge over their global counterparts, due to lower facility and development costs, strategic partnership plans for clinical trials, future commercialization with companies in the US and the European Union (EU), and strong scientific and technical framework ensuring world-class quality.Indiacan emerge as one of the leaders in global biologic development by the end of this decade. Critical factors for Indian companies to succeed in the biosimilars market are an appropriate marketing structure as well as the financial resources to develop the products and to accept higher upfront risks in development, commercialization and capital investment.


Table of Contents

1. India Biosimilar Market Overview


2. Indian Market for Biosimilar by Drug Class


3. Biosimilar Pipeline Analysis


4. Biosimilar Development Capabilities of Indian Players: Partnerships & Acquisitions

4.1 Mergers & Acquisitions

  4.2 Development & Marketing Partnership

    4.2.1 Dr. Reddy’s Laboratories & Merck Serono

    4.2.2 Biocon & Mylan Inc

    4.2.3 Ranbaxy & Pfenex


5. Factors Driving the Market

  5.1 Regulatory Framework for Biosimilars

  5.2 Cost Advantage of Biosimilar Development

  5.3 Biologics Patent Expiration

  5.4 Cost Saving to Healthcare System


6. Guidelines for Development & Marketing of Biosimilar

  6.1 Fundamental Principles for Manufacturing of Biosimilar

    6.1.1 Reference Biologic

    6.1.2 Biosimilar Development Process

    6.1.3 Quality Considerations for Biosimilar

    6.1.4 Quality Comparison Between Biosimilar & Reference Biologic

  6.2 Preclinical Pharmacodynamic & Toxicology Studies

  6.3 Pharmacokinetic & Pharmacodynamic Studies for Conducting Clinical Trial

  6.4 Approval for Marketing of Biosimilar

  6.5 Pharmacovigilance & Adverse Drug Reaction Reporting

7. Indian Biosimilar Market Future Outlook

  7.1 Domestic Market Expansion

  7.2 Contract Manufacturing Opportunity


8. Indian Biosimilar Drugs to Enter the US & European Market

9. Competitive Landscape

  9.1 Dr.Reddy s Labs (DRL)

  9.2 Intas Pharmaceuticals Ltd.

  9.3 Biocon Limited

  9.4 Wockhardt Limited

  9.5 Shantha Biotechnics Limited

  9.6 Reliance Life Sciences

  9.7 Cipla


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