Biotech Values

[DewDiligence]

...data on the efficacy/safety of this [Lovenox] knockoff? I would like to understand what was the regulatory bar set in India to allow a generic Lovenox.

The Lovenox knockoff in India (as is the case for the Copaxone knockoff there) is marketed as a non-substitutable branded generic, and hence the sponsor did not need to show sameness to Sanofi’s Lovenox to obtain approval. The efficacy and safety requirements for approval, therefore, were essentially the same as for any other low-molecular-weight heparin drug.

The official requirements for drug approval in India are set forth in a 600-page government document (http://www.wipo.int/export/sites/www/tk/en/laws/pdf/india_drugsact.pdf ); however, the salient point about the Indian market is that the technology threshold for a drug to be approved is low compared to the US and EU. This is partly a consequence of the fact that India did not allow composition-of-matter patents on drugs until about five years ago.

The relatively low threshold for drug approval in India has been a cause for concern and political maneuvering, especially when it comes to knockoffs of biologics and such complex-mixture drugs as Lovenox and Copaxone. The following excerpt is from a recent article in The Times of India (which has the distinction of being the most widely read English-language newspaper in the world):

http://timesofindia.indiatimes.com/india/Bio-drugs-a-blessing-but-need-regulation/articleshow/6761631.cms

Bio-similars would make health care more affordable because they cost one-third of bio-pharmaceuticals but manufacturing procedures have to be stringent. "Their safety and efficacy is highly dependent on the robustness and monitoring of quality aspects as even minor changes can affect the body," says Dr Anoop Misra, head of the department of diabetes and metabolic diseases, Fortis Hospitals. "Due to certain laxities, it's easier for bio-similars to get into the Indian market than abroad."

That’s quite an understatement, actually.