July 13, 2017, is the day for the review of FDA’s Oncology Drug Advisory Committee (ODAC) will review biologics license applications for biosimilars to trastuzumab (Herceptin) and bevacizumab (Avastin).
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.
Enhancing Adoption of Infused Biosimilars for a Sustainable Future
October 30th 2024An IQVIA report highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Strengthening the Supply Chain: Key Insights From FDA Commissioner Dr Robert Califf
October 25th 2024At the GRx+Biosims conference, FDA Commissioner Robert Califf, MD, stressed the urgent need for data transparency in the global supply chain and the role of collaboration and artificial intelligence in ensuring the resilience of biosimilar and generic drug production.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.