Biocon receives approval to sell its first generic in EU

The Biopharma major received the approval for a drug to reduce cholestrol

Biopharma major Biocon has received its first generic formulations approval in the regulated markets for a drug to reduce cholesterol. The company will begin selling its rosuvastatin calcium tablets indicated for hyperlipidemia or mixed dyslipidemia in 15 European countries starting from FY17.

“This is indeed a proud moment for Biocon’s small molecules business,” said Kiran Mazumdar-Shaw, chairman and managing director of Biocon. “This approval paves the way for Biocon to launch rosuvastatin calcium tablets in several European countries.”

Biocon was the first generic company to receive the Certificate of Suitability for the formulation from the European Directorate for the Quality of Medicines. The move will allow the company to address a $1.2 billion opportunity that exists in Europe. It will collaborate with regional partners to market the drug.

The approval will also make it easier for Biocon to get regulatory clearance to sell its drugs in emerging markets, which follow what US and European regulators say. It will also boost Biocon’s generic formulations business, which is targeting 20-25 filings over the next few years. “The European approval for Biocon’s generic version of rosuvastatin calcium underscores Biocon’s unique strengths in the chronic therapies space,” said Arun Chandavarkar, chief executive officer and joint managing director of Biocon. “It augurs well for this nascent business, which will be one of our growth drivers in the coming years.”

The company is also setting up a new facility in Bengaluru for developing and manufacturing new potent oral solid dosage formulations, which will help it grow in the generics space. The Biocon stock rose 4.49 per cent to Rs 463.95 soon after the announcement was made.