How to Ensure the Safety of Biosimilars

Archana Shanker and Devinder Singh Rawat discuss the rise and regulation of biosimilar biologics in the Indian pharmaceutical market.

Biologics are an important component of the pharmaceutical industry and have grown exponentially in the last decade. In recent years, the pharmaceutical industry has tended to developing biopharmaceutical-based drugs. Most successful biologics are on the verge of patent expiry or have already expired. Furthermore, biotechnological medicine has shown huge potential in curing the unmet demand of small drug molecules. These factors have caught the attention of the global pharmaceutical industry, and have polarised the pharmaceutical industry towards biologic products. Biosimilar biologics are expected to become the most important economic and therapeutic drivers of the pharmaceutical market in India.

This article was published in IP Focus Life Sciences 2013.

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