Patent wins for Pfizer in India, where NPPA looks to be disbanded

Even as a key regulatory agency that decides the list and prices of essential drugs in India is set to take on a new avatar (form) with the government looking to disband the National Pharmaceutical Pricing Authority (NPPA), US pharma giant Pfizer (NYSE: PFE) has received a major fillip in India by securing two Indian process patents related to its blockbuster drug etanercept. These two decisions have rocked the drug sector, reports The Pharma Letter’s India correspondent.

Etanercept is sold under the brand name Enbrel in several countries including the USA, and is a TNF (tumor necrosis factor) inhibitor to treat autoimmune diseases. Launched during 1998, Enbrel is approved for moderately to severely active rheumatoid arthritis.

Enbrel is Amgen's top seller, responsible for almost 27% ($5.8 billion) of the company's product sales over the past four quarters. First-half 2016 sales grew 16% year-over-year to $2.87 billion. Pfizer holds the rights to market and sell the biologic outside the USA and Canada. The drug accounted for $1.5 billion in sales for Pfizer from outside the USA and Canada. In India, Pfizer has managed the win against pre-grant oppositions filed by Mylan (Nasdaq: MYL) and Biocon (BSE: 53252), India’s largest biotech firm.