India launches 'similar biologics' guidelines at BIO2012

Developed by India's Department of Biotechnology (DBT) and Central Drugs Standard Control Organisation (CDSCO) as well as industry and academics the guidelines are intended as a 'clear regulatory pathway for manufacturers of similar biologics' and will be applied to products filed from today onwards.

Under the guidelines manufacturers must prove similarity to a reference product, either an innovator drug licensed in India or one approved elsewhere with four years of postmarket safety data. 

Government spokesman S Raghavan said: "In India there is a growing demand for the development of similar biologics as a consequence of pharmaceutical products reaching the end of their patent life. With this increased interest among biotech companies the Government felt the need to streamline the regulatory process into a well-defined set of guidelines​."

"We the Government expect these guidelines to provide guidance to both applicants and regulators and adherence will ensure that consistent science-based and data-driven standards are applied to the regulatory process​."

Balancing act​

DBT Secretary Maharaj Bhan went into more detail about the rationale for the guidelines, telling attendees they were designed with issues like access to medicine and international investment in mind.

"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​."

Dr Bhan explained that - in general - international manufacturers' prices are similar to those of local producers if they are able to make their drugs in India and cautioned that such companies will not be attracted unless a clear regulatory framework is in place.

"For me this [the biosimilars guidance] creates an pathway for local and international comapnies to invest in biosimilar development with manufacturing in India​."

Legal issues​

He aso suggested the guidelines may help address some of the legal issues involved in selling drugs in India - particularly regarding litigation relating to IP.

"We dont want the global and local industries to be in conflict all the time, there needs to be a more harmonius relationship. It [the guidelines] will give a very clear message to everyone...that the Indian regulatory system is capable of taking a scientific view of things and not necessarily worrying about trivial advantage in one direction or the other.​"

At time of publication the guidelines were only available in hardcopy despite assurances they would published on the DBT and CDSCO websites to coincide with the press conference.