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Biocon’s Biosimilar Ambitions Get A Boost With European Site Approval

 
• By Penelope MacRae

Leading Indian biotech firm Biocon has got the green light for a biosimilar manufacturing facility from Europe’s drug regulator, paving the way for the company’s growing biosimilars portfolio to gain greater European market access.

Inspected
The approval follows an inspection in March • Source: Shutterstock

The European Medicines Agency has approved Biocon’s biosimilar manufacturing facilities in the southern Indian city of Bengaluru after an inspection in March. The decision will help Biocon exploit expanding EU biosimilar market opportunities. The EMA’s award of its certificate of good manufacturing practice compliance coincides with the advent of what analysts call “payback time” for Biocon after years of investment in biologics R&D. Analysts expect the biologics business to drive high double-digit Biocon revenue growth over the next few years.

Biocon is already taking a leading role on biosimilars in Asia, with a portfolio spanning recombinant human insulin and insulin analogs to monoclonal antibodies and other biologics for diabetes, oncology and immunology

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