Pharmaceutical Regulatory Affairs: Open Access

ISSN: 2167-7689

Open Access

Biosimilars: an Emerging Market Opportunities in India


Rushvi P, Charmy K, Nirav C and Narendra C

In recent few years, there are many epic Biological products are going off patent which has generated an abridged route for the Biosimilars products which relies on the extensive comparability testing against Reference Biological Products (RBP) assuring product’s quality, safety and efficacy. Biosimilars are product similar to biologics but not indicate to them. Thus they require distinct marketing approval with abounding documentation as they are not generic version of biologics. These made regulatory and administrators of different countries to establish strict balance between the cost benefit and risk management of the product. The first draft guideline for Biosimilars was established by Europe, subsequently Japan and USA has developed the draft guidelines. While recently India has established the biosimilars guideline in June 2012. India has vigorous Pharmaceutical Industry for the generic drug while it can become an emerging market for the Biopharmaceutical drug. The regulatory structure for the biosimilars in India is depicted in this article with comparison of the biosimilars guidelines established by India and WHO. The approval process will be based authenticating a comparability quality between the biosimilars products and original product due to small alteration may lead to intolerable modifications in safety and efficacy. In many cases nonclinical studies are more difficult and potentially expensive to perform where biosimilars are highly species specific. Thus there is need for stringent regulatory guidelines. The biosimilar market will soon be thriving above $ 80 billion price of drugs in next seven years.


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