Biocon receives first generic formulation approval in EU

The approval will enable the company to address $1.2 billion opportunity, starting FY17

Biocon has received European approvals for its Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets, a generic equivalent of Crestor tablets, indicated for hyperlipidemia or mixed dyslipidemia. This first generic formulations approval in the regulated markets marks an important milestone in Biocon’s small molecules strategy of forward integration from APIs to finished dosages.

The approval through decentralised procedure will open the doors for Biocon to over 15 European countries and will enable the company to address $1.2 billion opportunity, starting FY17.

Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon said, “This is indeed a proud moment for Biocon’s small molecules business. This approval paves the way for Biocon to launch Rosuvastatin Calcium tablets in several European countries. We plan to collaborate with regional partners in the near term to provide access to this affordable generic and thus help patients and governments to bring down their healthcare spends.”