Asia's premier biopharmaceuticals company Biocon Ltd. announced on Monday its first generic formulation approval to make Rosuvastatin calcium tablets in the European Union (EU).
The launch of Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets -- a generic equivalent of AstraZeneca's cholesterol drug Crestor -- indicated for hyperlipidemia or mixed dyslipidemia, has been planned for FY17.
The company believes that this first generic formulation approval in the regulated markets marks an important milestone in Biocon's small molecules strategy of forward integration from APIs to finished dosages. It will enable the company to address $1.2 billion market opportunity in over 15 European countries.
"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," stated Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw.
Biocon also aims to rev up its generic formulations business with a target of 20-25 filings over the next few years and the new potent oral solid dosage formulations facility, coming up in Bangalore, will enable the business expansion. The company is also working on dossiers to introduce these formulations in emerging markets, where regulatory clearances are primarily based on approvals given by regulators in the US / EU.
"The European approval for Biocon's generic version of Rosuvastatin Calcium underscores Biocon's unique strengths in the chronic therapies space and our compliance with global standards that enable us to achieve the highest quality standards for all our products. It augurs well for this nascent business, which will be one of our growth drivers in the coming years," said Biocon CEO and Joint Managing Director Dr. Arun Chandavarkar.
Biocon was the first generic company to receive a Certificate of Suitability (CEP) for Rosuvastatin Calcium API from the European Directorate for the Quality of Medicines (EDQM). CEP certification indicates that an API is suitable for use in medicinal products in the EU.
On Feb. 12, Biocon Ltd. closed at the BSE at Rs 444, down Rs 6.75. The 52-week high of the share was Rs 473.95 and the 52-week low was Rs 449.40.