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

The Directors: Candace Johnson and Jonathan Friedberg on living through uncertainty at NCI, payment woesDirectors of two neighboring cancer centers in Upstate New York will face challenges, but “we’ll get through it”

Senators slam Bhattacharya for deflecting responsibility for NIH cuts, upheavalSusan Collins: Trump’s 40% cut is “so disturbing”

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Insights from ASCO 2025: Real-world evidence drives clinical decision-making

The Cancer Letter receives nine journalism, design awards

Never miss an issue!

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The Directors: Candace Johnson and Jonathan Friedberg on living through uncertainty at NCI, payment woes
Directors of two neighboring cancer centers in Upstate New York will face challenges, but “we’ll get through it”

Senators slam Bhattacharya for deflecting responsibility for NIH cuts, upheaval
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In first NCAB meeting since Trump’s inauguration, Lowy reflects on funding choices in lean times
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CRC patients with cannabis use disorder may have higher odds of death within five years of diagnosis
Observational study suggests that clinicians should be cautious when recommending cannabis to manage cancer symptoms