Biogenerics - Opportunities and Challenges Ahead

Raman Sehgal

Abstract: Biotechnology has already provided a wide range of products for the treatment of disorders like Diabetes, Hemophilia, Growth Deficiency and Hepatitis C. In the years to come, biotechnology will continue to provide major breakthroughs in the field of medical research. Apart from the diseases which have previously eluded the treatment (Multiple Sclerosis, AIDS, Parkinson's disease, Alzheimer's disease, Cancer, Bronchial asthma), with scientific advances, it will also provide better alternatives to the existing conventional treatments.

There is no accepted and well recognized definition for 'BIOGENERICS'. On review of the recent literature, presentations, articles and studies, it was observed that there are various acronyms used frequently; some of them are Biosimilars, Follow on Biologicals / Follow on Proteins, Biocomparables and Off - patent biopharmaceuticals. This article broadly examines some of the basic concepts, terms, paradigms and other issues concerning BIOGENERICS.

A Biogeneric can be defined as a protein product intended to be 'sufficiently' similar to an approved product to permit the applicant to rely for an approval based on certain existing scientific knowledge about the safety and efficacy of the approved product. It is a generic alternative to a biopharmaceutical. Similarly, Follow on Biologicals / Follow on Proteins are biological products that are intended to be used interchangeably with the reference product. By having similar action, they could be used as an alternative and cheap therapeutic entity. As with pharmaceutical generics, these biogenerics are essentially similar to an original biopharmaceutical whose patent has expired, are currently approved through a simplified abbreviated registration process, and are sold under the generic substance name instead of an established brand name (e.g., EPO as opposed to Epogen).

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