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Biosimilars: India Update
Datamonitor, Oct 2011, Pages: 51
Currently, all biologics in India, including innovative and copy biologics are approved as new drugs. However, in July 2011, the Department of Biotechnology proposed draft guidance outlining an abridged procedure for the preclinical evaluation of similar biologics in India, with the DBT currently awaiting draft guidance on clinical trials for biosimilars from the Drug Controller General of India.
Features and benefits
- An overview of biologic regulations in India
- Insight into the key drivers and resistors to biologic uptake in the India
- Assessment of the key marketed and pipelines domestically developed biologics in India
- Provides a snapshot of key major biologic players and the strategies they have implemented
Highlights
- Due to limited R&D capabilities in terms of finance and expertise, most domestic biopharmaceutical companies have focused on manufacturing simple copy biologics, and as a result the simple biologic market is highly competitive, resulting in significant downward pressure on pricing.
- A number of manufacturers are now developing more complicated second-generation copy biologics such as PEGylated versions of erythropoietin and filgrastim and monoclonal antibodies, which though more expensive and complex to develop, can be priced at a premium, and compete in a much less crowded market than that faced by first-generation biologics.
- Despite the low price of copy biologics compared to originator brands, the domestic market is restricted by limited health insurance coverage and therefore poor access to biologic drugs. Also, issues regarding the quality and safety of some domestically manufactured biologics remain a concern among patients and physicians.
Your key questions answered
- Evaluate the evolving copy biologics market, the drivers and resistors to uptake, and future opportunities for domestic players in India.
- Gain insight into the strategies employed by copy biologic producers seeking to enter or expand their presence in the Indian market place.
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