FDA approves the first biosimilar treatment for cancer

On September 14th 2017, the FDA announced the first approval for a biosimilar drug to treat cancer. This is the biosimilar drug, marketed by Amgen, to Roche’s Avastin® (bevacizumab). The brand name Amgen will use for the biosimilar is Mvasi®. Even though Amgen has received the approval, there has not been any news about the launch date of the drug to the market or the price for the public. Mvasi® has received approval for metastatic colorectal cancer, non-squamous non-small cell lung cancer, glioblastoma, metastatic renal cell carcinoma and cervical cancer, each one with their own specifications about what clinical stage should they be administered in and if it is to be administered along with other therapies.

We understand the importance of all the work behind clinical trials and how this can determine the approval of a new drug to the market. This is why we keep our eyes on the patients, who are the ones that can benefit of new treatment options for several diseases.

At our research center, we have conducted protocols using biosimilar drugs that are targeted for oncologic diseases. We understand the challenges this kind of protocols have, such as having a blinded and un-blinded team for the drug management, appropriate handling of adverse events, accurate patient selection, correct dose calculation, among others.

We are committed to contributing to the approval of new biosimilar drugs. If you’re interested in conducting a biosimilar trial, please contact us and we will provide more information about our experience with these trials.