With the tabeling of the “Access to Life-Saving Medicine Act” – H.R. 6257 on September 29, 2006 by Rep. Waxman and Senators Charles E. Schumer and Hillary Rodham Clinton has paved way ahead for Biogenerics. This will establish a procedure with which the USFDA will be able to approve bioequivalent and yet low cost biotech drugs. Biotech or biologicals or biophamaceuticals are the drugs, which are produced from living cell cultures rather than synthesized chemically in labs and are among the fastest growing and expensive segments of the health care budget of the country. Currently as on date, there was no approved regulatory pathway for approval of generic biotech drugs and innovators of biotech drugs were pricing their drugs at will.

The Patent Price Competition and Patent Term Restoration Act commonly as known as Hatch-Waxman Amendments Act of 1984 paved way for slashing down the cost of prescription drugs. Also about $ 10 b of biopharmaceuticals are likely to go off-patent in the coming five years and the introduction of such a bill is certainly a welcome step towards the realisation of setting up of process of regulatory approval of biogenerics.

Regards.

Gautam Bakshi

Manager – IPR

Intas Biopharmaceuticals Ltd.

Ahmedabad, Gujarat, India.