BAAR, Switzerland--(BUSINESS WIRE)-- Biopartners GmbH has announced that it has received EU marketing authorization from the European Commission for Ribavirin Biopartners 200mg film-coated tablets. The product is intended for the treatment of chronic hepatitis C infection as part of a combination regimen with peginterferon alfa-2b or interferon alfa-2b.
Commenting on the news, Dr Conrad Savoy, Biopartners’ CEO said: “We are very satisfied indeed to have received European marketing authorization for Ribavirin Biopartners. This approval marks an important milestone, both for Biopartners and also for European healthcare providers, as it ushers in a new era of lower cost therapy.” Dr Savoy continued: “The granting of the EU marketing authorization completes a very efficient and successful review procedure, with Ribavirin Biopartners receiving a positive opinion from the CHMP in only 8 months. We believe this fast review and approval process underlines the strength of the data presented.”
The studies submitted in the application dossier demonstrated the appropriate quality of Ribavirin Biopartners 200mg film-coated tablets and its bioequivalence with the reference product - Rebetol®.
About Biopartners GmbH
Headquartered in Baar, Switzerland, with an affiliate in Germany, Biopartners is a global biopharmaceuticals company and a leader in the emerging field of multi-source biopharmaceuticals. Biopartners’ mission is to develop optimized first generation biopharmaceuticals and second generation innovative formulations, such as long-acting forms that may improve patient compliance. Biopartners is developing a range of biopharmaceutical products that may offer clinically relevant therapeutic benefits across several therapeutic areas. Biopartners is owned by Bioton Group S.A.
About the Bioton Group S.A.
Headquartered in Warsaw, Poland, a Warsaw Stock Exchange listed company, Bioton S.A. is among the first four companies worldwide being able to produce recombinant human insulin. This product is already registered on the most attractive markets. Bioton is able to pursue its strategic objectives of protecting Patients’ health and improving the quality of their lives by participating in research and development projects and promoting the expansion of its product portfolio to deliver to the market most innovative pharmaceutical products. Bioton Group developed its global position by targeting the most attractive insulin markets – among them Poland, Russia, Ukraine, China, India and other Asia Pacific countries. Bioton’s aim is to build strong, international operations focused on sales of insulin and other biotech products, development of new clinically important drugs and strategic alliances with world’s leading pharmaceutical companies.
Dr Conrad Savoy, CEO
Phone: +41 (0)41 766 20 80
KEYWORDS: Europe Germany Switzerland
INDUSTRY KEYWORDS: Health Biotechnology Pharmaceutical