Companies such as Biocon, Panacea Biotec and Avesthagen will now have to follow a fresh set of norms while seeking marketing approval for their biotech products in India. The new norms mandate that companies can develop a biosimilar or a biotechnology generic drugs only by referring to an innovator biologic drug approved in India. The guidelines, though, fail to address the issue of testing of such drugs with no details on patient size for clinical trials.
The guidelines, which have been prepared after five years of intensive engagement, will be implemented from August 15, a government official said.
An official in the office of drug regulator said this was the first set of guidelines for biosimilars and, therefore, the attempt was to keep them generalised. “Once these guidelines are adopted by the industry, we will start working on standard operating procedures, which will contain details about sample size, etc,” he added.
|HOW BIOSIMILAR NORMS WILL PLAY OUT
- Govt to implement new biosimilar guidelines from Aug 15
- New norms do not specify patient size for clinical trials
- Innovator drug reference in India mandatory for approval of biosimilar
- If innovator biologic is not authorized in India, it should have been licensed and marketed for at least 4 years
- At present, there are no separate guidelines for biosimilars in India
The department of biotechnology, along with the drug regulator, has framed the guidelines that outline data requirements for pre-clinical and clinical trials. It also talks briefly about pre-marketing and post-marketing data, but does not go into the specifics.
Until now, there were no separate set of guidelines for biosimilars in India, and such drugs were approved on the basis of general guidelines. There have also been instances where biotechnology products were approved without conducting clinical trials on enough number of patients.
According to the new set of guidelines, in case the reference biologic is not authorised in India, it should have been licensed and marketed for at least four years, with significant safety and efficacy data. “In case of no medicine or only palliative therapy is available or in a national healthcare emergency, this period of four years may be reduced or waived,” the guidelines say.
The proposed guidelines are also expected to boost the industry in the international space by buying credibility for drugs developed and manufactured in India. “The guidelines are well harmonised,” Panacea Biotec’s joint managing director Rajesh Jain said. “They will help domestic biotechnology companies market their products in the International market.”
Recently, Sri Lanka had deregistered some biotechnology drugs manufactured by Indian companies, as they found there are no set manufacturing and regulatory standards for such products in India. This prompted the government to fast track the process of finalising the norms.
According to Jain, the guidelines will also help reduce the development time and cost involved in biosimilars.
While Europe has had such guidelines in place for some time, the US also introduced norms for biotechnology products recently.