Wednesday, March 31, 2021
The European Commission (EC) has approved mAbxience’s MB02 biosimilar to Avastin® (Bevacizumab), in Europe.MB02, to be commercialized as Alymsys® and Oyavas®, is highly similar to the reference medicinal product and data has shown a comparable quality, safety and efficacy to Avastin®. MB02 is intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
“We are currently witnessing a period of vital importance globally, with a key focus on the healthcare system and its sustainability” said Emmanuelle Lepine, General Manager at mAbxience.
“The launch of our Bevacizumab under the trademarks Alymsys® and Oyavas® in the European market will be a perfect example of how innovation and cutting-edge R&D technology can be applied to obtain a high quality, affordable medicine which, as well as providing alternatives for the healthcare system, will also improve patient access to costly treatments.”
mAbxience is a fully integrated global biopharmaceutical company specialising in the development, manufacture and commercialization of monoclonal antibodies, and forms part of the pharmaceutical group Insud Pharma. Founded in 2010, mAbxience operates three state of the art facilities, located in Spain and Argentina. mAbxience is working on several biopharmaceutical products spanning to different therapeutic areas. In 2014 mAbxience launched its first biosimilar, Rituximab (Product Code: RTXM83-MB01), which is now approved and marketed in a range of markets worldwide. Its second product, Bevacizumab (Product Code: BEVZ92-MB02), was first developed and launched in Latin America in 2016.
mAbxience is committed to the quality, safety and efficacy of its medicines. The mAbxience team is passionate about patient care and expanding access to its biopharmaceutical medicines all over the world. The Company’s mission is to improve patient access to quality treatments for conditions that require costly medications and positively contributing to the sustainability of healthcare systems.
The Insud Pharma Group was founded by Dr. Hugo Sigman and Dr. Silvia Gold and has over 40 years’ experience in the pharmaceutical sector and employs over 6,000 professionals worldwide.
Some of the statements in this press release other than statements of historical fact, may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties, same as our business, as well as each product we develop and market, is subject to various risks and uncertainties beyond our control. Forward-looking statements represent the judgment of mAbxience’s management as of the date of this release, and mAbxience disclaims any intent or obligation to update any forward-looking statements contained herein, which speak as of the date hereof.