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Indian Pharmaceutical Industry and Opportunities in Biogenerics |
Rahul Baghla |
The term “biogeneric” can simply be defined as the pharmaceutical preparation based on a biologically active substance, it is the generic alternative of a biopharmaceutical or biologic, which is a copy of the original product. Biogenerics can be characterised as
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Essentially similar to an “original product”,
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Incorporating an active substance for which the patent has expired,
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Approved through a simplified registration procedure,
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Sold under a Common Name
Unlike the more common "small-molecule" drugs, biologics generally exhibit high molecular complexity, and may be quite sensitive to manufacturing process changes. The follow-on manufacturer does not have access to the originator's molecular clone and original cell bank, nor to the exact fermentation and purification process. Finally, nearly undetectable differences in impurities and/or breakdown products are known to have serious health implications. This has created a concern that copies of biologics might perform differently than the original branded version of the drug. However, similar concerns also apply to any production changes by the maker of the original branded version. So new versions of biologics are not authorized in the US or the European Union through the simplified procedures allowed for small molecule generics. In the EU a specially-adapted approval procedure has been authorized for certain protein drugs, termed "similar biological medicinal products". This procedure is based on a thorough demonstration of "comparability" of the "similar" product to an existing approved product. In the US the FDA has taken the position that new legislation will be required to address these concerns.
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