Featured in Health Business Daily, Oct. 31, 2017

ODAC Favors Approval of Biosimilars for Two Oncology Blockbusters

Reprinted from SPECIALTY PHARMACY NEWS, a monthly newsletter designed to help health plans, specialty pharmacies, pharma companies, providers and employers contain costs and improve outcomes related to high-cost specialty products. Subscribe today!

By Angela Maas, Managing Editor
July 2017Volume 14Issue 7

If the FDA chooses to follow the recommendation of one of its advisory committees, the agency could help clear the way for biosimilars of two blockbuster oncology treatments to come onto the U.S. market.

On July 13, the Oncologic Drugs Advisory Committee (ODAC) voted unanimously recommending approval of Amgen Inc. and Allergan plc.’s ABP 215, a biosimilar of Genentech Inc.’s Avastin (bevacizumab), and Mylan GmbH and Biocon Ltd.’s MYL-1401O, a biosimilar of Herceptin (trastuzumab), also from Genentech, a Roche Group company.

ODAC members voted for approval of ABP 215 for six of Avastin’s indications — for colorectal cancer (two indications), non-small cell lung cancer, glioblastoma, renal cell carcinoma and cervical cancer — but did not consider its two ovarian cancer indications, which have orphan drug exclusivity until 2021 and 2023. Patents for the other indications expire in 2020. The committee also voted in favor of approving MYL-1401O for all of Herceptin’s indications: HER2-positive breast cancer in the adjuvant and metastatic settings and HER2-positive gastric cancer, an indication that has orphan drug exclusivity until Oct. 20. Herceptin’s patents expire in 2019. ABP 215 has a Biosimilar User Fee Act target action date of Sept. 14, while MYL-1401O’s is Sept. 3.

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Avastin had worldwide sales of $6.783 billion in 2016, with $2.964 billion coming from the U.S. Herceptin had $6.782 billion in worldwide sales last year, with $2.509 billion in U.S. sales. Express Scripts Holding Co. has estimated $250 billion in savings over 10 years if 11 biosimilars, including ones for Avastin and Herceptin, are approved (SPN 12/14, p. 1).

View the meeting materials at http://tinyurl.com/y9ggy7kq.


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