Considering the expiration of patents of best selling biologics, greater regulatory support, scientific expertise, lower labour and goods costs, and smooth access to both domestic and regional markets, India has a tremendous potential to emerge a key player in manufacturing and marketing of biosimilars, the follow-on versions of biologic drugs, according to experts.
Patents for over six top selling biologics viz. Humira, Enbrel, Rituxan/MabThera, Avastin, Herceptin and Remicade will be expired between 2015 and 2020 allowing manufacturers of biosimilars to seek US FDA approval for generic biologics. More than 160 biosimilars have been reported in different stages of development for these six best selling biologics.
The collaborations will be fundamental to Indian industry’s success in biosimilars. While Indian industry has now developed high level of technical capability, given the time sensitivity in biosimilars, asset level collaborations for technology access could accelerate time to market and global competitiveness, said Vijayaraghavan.
Compared to the US, the Indian regulatory bodies have been granting approval to Indian-manufactured generic biologics with reference products that have received approval in the US or Europe under an ad hoc abbreviated approval pathway for several years. There has been twenty biologics approved by India under this regime. There are several cases where the Indian regulatory authorities have approved these biologics based on phase 3 bioequivalence studies consisting of around 100 patients.
Biotech drugs can treat diseases like cardiac, diabetes and cancer. An increase in the number of tertiary healthcare centres across the country has been resulting in greater usage of biotech products.
Original article: http://pharmabiz.com/NewsDetails.aspx?aid=98346&sid=1&fromNewsdog=1