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

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer PanelThe cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

Two years after FDA’s breast density notification rule, there is still no standard for follow-upSo far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy“Because it works in one neural system, you begin to wonder: Well, what about another?”

ASCO Genitourinary Cancers Symposium: Pioneering breakthroughs, optimizing patient outcomes

Trump targets HHS in $810M appropriations clawback

Never miss an issue!

Login

With Year One metrics in hand, Letai is ready to “bring it home” in Year Two
“I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts”

Michael Caputo appointed to President’s Cancer Panel
The cancer survivor and political operative says his appointment signals Trump’s interest in cancer, survivorship

Two years after FDA’s breast density notification rule, there is still no standard for follow-up
So far, 38 million patients have received a dense breast notification. Now what?

MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy
“Because it works in one neural system, you begin to wonder: Well, what about another?”