For Biocon, regulatory nod to give boost to biosimilar monetisation

EU's clearance to firm's Bengaluru plant increases chances of its drug approval, launches

Biocon’s recent announcement of it receiving good manufacturing practice (GMP) certificate from European Union’s drug regulator for its Bengaluru-based sterile manufacturing facility should ease concerns. 

The latest clearance to this plant, which had received some observations after inspection by UK MHRA in March 2018, paves the way for drug approvals and launch of the company’s biosimilar in Europe. 

Two biosimilar approvals of oncology drugs, Trastuzumab and Pegfilgrastim, are already awaiting clearance for launch in Europe. Biocon had resubmitted the market reauthorisation applications for both the products in November 2017 and is awaiting the European Medicines  Agency's (EMA) and the Committee for Medicinal