Currently Viewing:
Currently Reading
What's the Magic Payment Mix for Medicare Primary Care Providers?
December 11, 2017 – Allison Inserro
Sanofi's Insulin Lispro Follow-On, Admelog, Wins FDA Approval
December 11, 2017 – Mary Caffrey
The Past, Present, and Future of HIV Funding
December 11, 2017 – Jaime Rosenberg
What We're Reading: Harsh Flu Season; Potential Hospital Giants Merger; ACA Sign-Up Deadline
December 11, 2017 – AJMC Staff
ICER Seeking Public Comment About Migraine, Plaque Psoriasis Treatments
December 11, 2017 – Allison Inserro
ADA 2018 Standards Address Drugs With CV Benefits, Hold Firm on Blood Pressure
December 10, 2017 – Mary Caffrey
Heavy Healthcare Use Precedes Start of Acthar Injection for Patients With Rare Infantile Spasms
December 09, 2017 – Mary Caffrey
UC San Diego Researchers Receive $600,000 Grant to Test PI3Ky Inhibitor
December 08, 2017 – Kelly Davio
5 Approvals and Updates From the FDA This Week
December 08, 2017 – Jaime Rosenberg

FDA Advisory Committee Confirms Support for Biosimilars to Trastuzumab, Bevacizumab

Surabhi Dangi-Garimella, PhD
The comittee voted 17-0 in favor of the Amgen/Allergan bevacizumab biosimilar candidate, ABP 215, and 16-0 in favor of Mylanís trastuzumab biosimilar candidate, MYL-1401O.
A 17-0 vote in favor of the Amgen/Allergan bevacizumab biosimilar candidate, ABP 215, and a 16-0 vote in favor of Mylan’s trastuzumab biosimilar candidate, MYL-1401O—that was the final tally following a vote by the FDA’s Oncologic Drugs Advisory Committee (ODAC) on 2 pioneer biosimilar candidates for cancer treatment.

Both the reference drugs, trastuzumab (Herceptin) and bevacizumab (Avastin), are manufactured by Roche and are blockbusters in their own right: both drugs together brought in $5.6 billion in sales in 2016. Bevacizumab is indicated for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous non–small cell lung cancer (NSCLC), metastatic carcinoma of the colon or rectum, metastatic renal cell carcinoma, and other region-specific indications. Trastuzumab is indicated for the treatment of HER2-positive breast cancer, following surgery and for metastatic disease as well as for gastric cancer.

In a briefing document released prior to today’s meeting, the ODAC committee members stated that the “totality of evidence” submitted by Amgen showed that the lung cancer data can be extrapolated to other indications of bevacizumab. This was following evaluation of phase 3 data from the company, which showed the biosimilar candidate had similar safety and immunogenicity as the reference product in patients with NSCLC. However, a few ODAC members did raise concerns over extrapolating data from studies conducted in a single disease to multiple indications.

In a release prior to the beginning of the day’s proceedings, David Nicholson, chief R&D officer at Allergan, said, “ABP 215 is the first product of our collaboration with Amgen to reach this important milestone. If approved, ABP 215 has the potential to provide another high-quality treatment option for cancer patients and pave the way for additional high quality oncology biosimilars from Allergan and Amgen.”

ABP 215 has a Biosimilar User Fee Act (BsUFA) date of September 14, while the BsUFA for MYL-1401O is September 3.

Copyright AJMC 2006-2017 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
Welcome the the new and improved, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up

Sign In

Not a member? Sign up now!