Comments
Biocon has said that the US Food and Drug Administration (FDA) has accepted Mylan's biologics licence application (BLA) for MYL-1401O, a proposed biosimilar trastuzumab, for filing through the 351(k) pathway. Biocon has partnered with Mylan for a proposed biosimilar for treating HER2-positive breast cancers. Mylan President Rajiv Malik said: "The FDA acceptance of our BLA for proposed biosimilar trastuzumab marks an important step toward increasing access to this treatment option for patients in the US.” Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: “This development positions Biocon and Mylan among the first companies to be able to address the critical need of US patients for a high-quality biosimilar to treat certain HER2-positive breast cancers, in the near future.”
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.