The Indian Government launched its biosimilars guidelines at this year's BIO meetings. The guidelines are aimed at providing a "clear" regulatory pathway for manufacturers of biologic similars and will be applied to new filings now.
Manufacturers must prove similarity to a reference product -- either an innovator drug in licensed in India or approved elsewhere. There is also a requirment for 4 years post-market surveillance on safety data.
The motive for India to promote these guidelines is to encourage more domestic and foreign investment in biosimilars in India with an idea to increase product access and to reduce4 goverment spending on drugs.
Dept of Biotechnology secretary, Maharaj Bhan, said, "India needs drugs at reasonable prices so we have to worry about the issue of access so we have to spur innovation and manufacturing in India. We also need to create an environment where International companies will be interested in using India as a place to manufacture drugs." The latter comment relates directly to the previous blog post on India's need to raise GMP compliance.
Posted by Bruce Lehr Jun 25th 2012.