Life-Saving Oncology Biosimilars to be Reviewed by FDA's ODAC

On July 13, 2017, the FDA’s Oncology Drug Advisory Committee (ODAC) will review biologics license applications (BLAs) for 2 proposed biosimilars treating cancer. During the morning session, the committee will discuss BLA 761028 for ABP 215, a proposed biosimilar to Genentech/Roche’s bevacizumab (Avastin), submitted by Amgen Inc. During the afternoon session, the committee will discuss BLA 761074 for MYL-1401O, a proposed biosimilar to Genentech Inc’s trastuzumab (Herceptin), submitted by Mylan GmbH.

This is an important day for patients with cancer, such as those with breast cancer—the most common cancer diagnosed in the United States with more than 255,000 new cases expected in 2017—as the unmet need for access to life-saving and more affordable biosimilars treating cancer continues to move towards becoming a reality.

ABP 215

ABP 215 is being developed as a biosimilar to bevacizumab, which is approved in the United States, the European Union (EU) and other countries for the treatment of patients with unresectable, locally advanced, recurrent, or metastatic non-squamous non-small cell lung cancer (NSCLC) as well as metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications.

ABP 215 is a biosimilar candidate to bevacizumab, a recombinant immunoglobulin G1 monoclonal antibody that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus preventing angiogenesis necessary for the maintenance and growth of solid tumors. The BLA submission for the proposed biosimilar to Avastin includes analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data. The phase 3 comparative efficacy, safety, and immunogenicity study, conducted in adult patients with NSCLC, confirmed no clinically meaningful difference with bevacizumab in terms of efficacy, safety and immunogenicity.

This is the first bevacizumab biosimilar application to the FDA and Amgen’s first oncology biosimilar candidate submitted for FDA approval. Amgen and Allergan are collaborating on the development and commercialization of bevacizumab as well as 3 other oncology biosimilars. Both companies are also independently developing biosimilars, and Amgen has a total of 10 biosimilars in its portfolio, one of which is FDA approved.

The expected availability of the bevacizumab biosimilar to cancer patients will be sometime after September 14, 2017, the Biosimilar User Fee Act (BsUFA) target action date set by the FDA.

MYL-1401O

MYL-1401O is being developed as a biosimilar to trastuzumab, which is approved in the United States, EU, and other countries for the treatment of patients with Human Epidermal Growth Factor Receptor 2 HER2-positive metastatic breast cancer and metastatic gastric cancer. MYL-1401O is a biosimilar candidate to trastuzumab, a monoclonal antibody that continuously blocks HER2 receptors that stimulate tumor proliferation.

The BLA submission for the proposed biosimilar to Herceptin includes a comprehensive package of analytical similarity, non-clinical and clinical data that will demonstrate the similarity of the proposed biosimilar trastuzumab to the reference product. This is the first trastuzumab biosimilar application to the FDA.

Mylan and Biocon are collaborating on the development and commercialization of trastuzumab as well as 5 other biologic products for the global marketplace. Mylan has a total of 16 biosimilar products in development and has one of the industry’s broadest biosimilars portfolios. The expected availability of the trastuzumab biosimilar to cancer patients will be sometime after September 3, 2017, the BsUFA target action date set by the FDA. There will be no legal hurdle blocking the potential US (and global) launch of its biosimilar because Mylan reached a settlement agreement with Genentech and Roche on March 13, 2017.