Biosimilar Companies In India Have Edge Over Their Global Counterparts

Release Date: 06-Sep-2012

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.

However, the biosimilars market does pose some challenges. The process to develop a biosimilar is more complex than that of developing a generic copy of a chemical-based compound. Furthermore, the regulatory framework is not completely finalized in both theUSand EU, which are the largest markets for biosimilars. Besides the regulatory and clinical development obstacles that are costly and time consuming, Indian players need to constantly upgrade their capabilities as their organizations mature. Some of these include joint venture and alliance management for collaborative research, contract research, contract manufacturing, developing technology transfer management and marketing arrangement for biosimilars globally.


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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