FDA accepts BLA for biosimilar MYL-1402O in cancer indications

FDA has accepted Mylan’s Biologics License Application or MYL-1402O, a proposed biosimilar to Avastin (bevacizumab), for review under the 351(k) pathway.

Mylan and Biocon sponsor MYL-1402O.

The BLA seeks approval of bevacizumab for first-line and second-line treatment of patients with metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line use for patients with non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma in combination with interferon alfa; and persistent, recurrent or metastatic cervical cancer.

The FDA goal date set under the Biosimilar User Fee Act is Dec. 27, 2020.

Mylan and Biocon’s proposed biosimilar bevacizumab is expected to be the third biosimilar from the partnered portfolio for cancer patients in the U.S. It is currently available in India and other developing markets.

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FDA accepts BLA for biosimilar MYL-1402O in cancer indications

YOU MAY BE INTERESTED IN

In The Headlines: Wafik El-Deiry on how “America First” means investing in NCI

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient livesIn a time of uncertainty, “react to the knowns, not the fear”

Grilled by Congress, Kennedy defends NIH and NCI budget cuts, freezes, and RIFsTo avoid “offending” pharma, NCI doesn’t study the causes of early-onset colon cancer, HHS secretary incorrectly alleges

Kennedy’s claims notwithstanding, NCI clinical trials are delayed, enrollments reducedNCI’s Steven A. Rosenberg: “Almost all patients are getting delayed by about a month, but then again, we’re turning away more patients.”

An opportunity for Trump: Position U.S. cancer science to lead the world

First exhibit at Museum of Medicine and Biomedical Discovery to focus on the history of cancer researchFrom despair to discovery to triumph

Never miss an issue!

Login

The Directors: Tom Lynch and Skip Burris on how NIH funding cuts imperil biopharma innovation—and cost patient lives
In a time of uncertainty, “react to the knowns, not the fear”

Grilled by Congress, Kennedy defends NIH and NCI budget cuts, freezes, and RIFs
To avoid “offending” pharma, NCI doesn’t study the causes of early-onset colon cancer, HHS secretary incorrectly alleges

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