Biocon was the first generic company to receive a Certificate of Suitability (CEP) for rosuvastatin calcium from the European Directorate for the Quality of Medicines (EDQM), which indicates that the API is suitable for use in medicinal products in the EU.
The approval is the company’s first generic formulation approval in the regulated market.
"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,” said Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw. “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."
According to the company, the approval will open doors for Biocon in more than 15 European countries, subsequently enabling the company to address a $ 1.2 bn market opportunity beginning in FY17. "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," it added.
Five mg, 10 mg, 20 mg and 40 mg tablets have been approved, as indicated for hyperlipidemia or mixed dyslipidemia.
"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,” said Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon.
“It augurs well for this nascent business, which will be one of our growth drivers in the coming years."
Biocon plans to continue growing its generic formulations business with 20 to 25 filings targeted over the next few years. Additionally, the company’s new potent oral solid dosage formulations facility in Bengaluru will enable further expansion.
The company filed an initial set of Marketing Authorization Applications (MAAs) in the EU and Abbreviated New Drug Applications (ANDAs) in the US for its rosuvastatin Calcium in FY15.