Home Alzheimer’s Disease FDA Accepts BLA for Proposed Biosimilar to Bevacizumab, MYL-1402O

FDA Accepts BLA for Proposed Biosimilar to Bevacizumab, MYL-1402O

The FDA accepted a biologics license application (BLA) for MYL-1402O, a proposed biosimilar to bevacizumab (Avastin), for review under the 351(k) pathway, according to Biocon Biologics and Mylan, the agent’s developer.

The BLA is seeking approval of MYL-1402O for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy, as well as first-line use for patients with non-squamous non-small cell lung cancer (NSCLC), recurrent glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa, and persistent, recurrent, or metastatic cervical cancer. 

A goal date under the Biosimilar User Fee Act (BsUFA) was set for December 27, 2020. The proposed biosimilar is currently available in India and other developing markets. 

“As we continue toward our goal of expanding access to cancer treatments…

Continue Reading to the Source


Please enter your comment!
Please enter your name here

Most Popular

Cause of Alzheimer’s disease traced to mutation in common enzyme

submitted by /u/scotsman81 Continue Reading to the Source

Reflections on Living With an Incurable Illness : braincancer

(I’ve checked with the moderators to make sure this is appropriate and a good fit for this subreddit. I'm a very private person, and...

This Foramen Magnum Meningioma almost killed me 18 years ago.

submitted by /u/dkrem Continue Reading to the Source

Patients, Family & Friends, and Healthcare professionals : braincancer

I am currently a PhD student based at the Marie Curie Palliative Care Research Centre at Cardiff University. My PhD is focussed on developing...

Recent Comments