FDA drug panel unanimously approves Avastin and Herceptin Biosimilars

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) today unanimously voted to recommend the approval of biosimilar versions of two of Genentech’s top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab).

Herceptin®, is used in treatment of HER2-positive breast cancer in the metastatic and adjuvant settings while Avastin is used in colorectal, ovarian, cervical, brain and renal cell cancers.

In the morning session, the ODAC members voted 17-0 in favor of approving Amgen's Avastin biosimilar ABP 215, for six of 8 originally approved indications for Avastin, as they are covered by orphan drug exclusivity until 2021 and 2023.

In the afternoon session, ODAC members voted 16-0 in favor of approving Mylan's Herceptin biosimilar candidate, MYL-1401O, for all of Herceptin's indications, including an indication for metastatic gastric cancer, which is protected by orphan drug exclusivity through 20 October 2017.

For both the drugs the FDA and committee members felt that there were no clinically meaningful differences between the reference products and the biosimilars. However, some members were worried about extrapolating the data from studies pertaining to single disease to multiple indications in actual clinical application.

Courtney J. Preusse, MA, ODAC's consumer representative and a research administrator at Fred Hutchinson Cancer Research Center in Seattle said, “I would like to strongly applaud the sponsor for equivalence results that were very solid and for what appears to be the first proposal for a biosimilar for a drug that's been on the market for almost three decades.”

To gain the approval, Mylan has submitted clinical trial data comparing MYL-14010 and European Union trastuzumab. The trial recruited 458 patients with untreated metastatic breast cancer, who were randomized to receive MYL-14010 or EU-trastuzumab in combination with a taxane, for a minimum of eight cycles.

Those patients whose disease was stabilized were put on single agent MYL-14010 or EU-trastuzumab for a period until the disease progressed or drug toxicity developed.

In an intention to treat analysis, overall similar response was achieved with both the drugs. No difference was observed in safety analysis also.

The FDA and ODAC report concluded that the clinical trials have  shown "that there are no clinically meaningful differences between MYL-14010 and US-Herceptin in terms of the safety, purity, and potency of the product."

Photo courtesy: Genentech