FDA Advisory Committee Confirms Support for Biosimilars to Trastuzumab, Bevacizumab

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.