Can India Repeat the Success of Generics in US (United States) Biosimilar Market? An Analysis of Current FDA’s Stand on Biosimilars

Moorkoth, Sudheer (2013) Can India Repeat the Success of Generics in US (United States) Biosimilar Market? An Analysis of Current FDA’s Stand on Biosimilars. Pharma Times, 45 (1). pp. 27-31.

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Abstract

After the enactment of Hatch Waxman Act, the outlook of generic pharmaceutical industry changed not only in US (United States), but also worldwide. This historic act perfectly balanced the need of consumers, generic industry and innovator companies. The generic approval pathway (ANDA; Abbreviated New Drug Application) created under this act allowed the proof of bioequivalency for approving a generic small molecule drug, thus avoiding lengthy and expensive clinical trials. Presently, Indian generics shares 30% of world generic market and 10% of US generic market. When it comes to biologics, the approval pathways for generics encompassed in the Hatch Waxman Act does not fit due to the complexity of biologics, which are mostly high molecular weight proteins. In 2010, the Biosimilar Act came into existence in US for approval of biosimilars. The guidelines specify a highly similar structure, and requirement of certain phases of clinical trials and immunogenicity studies for approval. Current FDA (Food and Drug Administration) guidelines on biosimilars are not much promising for the biosimilar industry as compared to the Hatch Waxman Act. This article critically analyses and compares the generic and biosimilar approval pathways and tries to find an answer to the question whether India can repeat its success in world generic market

Item Type: Article
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Depositing User: KMC Manipal
Date Deposited: 15 Feb 2013 10:15
Last Modified: 15 Feb 2013 10:15
URI: http://eprints.manipal.edu/id/eprint/78442

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