The FDA’s Oncologic Drugs Advisory Committee (ODAC) met on the afternoon of July 13th to discuss Biologics License Application (BLA) 761074 for Mylan’s biosimilar to Genentech Inc.’s Herceptin (trastuzumab).
The FDA’s Oncologic Drugs Advisory Committee (ODAC) met on the afternoon of July 13th to discuss Biologics License Application (BLA) 761074 for Mylan’s biosimilar to Genentech Inc.’s Herceptin (trastuzumab), MYL-1401O. MYL-1401O’s proposed indications include: Adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer; in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer; as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease; and in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
MYL-1401O is a humanized monoclonal antibody, which targets Human Epidermal Growth Factor Receptor 2 (HER2). This inhibits proliferation of tumor cells and activates antibody-dependent cell-mediated cytotoxicity, which activate tumor cell lysis, leading to the destruction of cancerous cells. The sponsor presented their analytical, non-clinical, and clinical data package, which demonstrated high similarity of MYL-1401O to the reference product. The sponsor concluded that the totality of evidence supports both the overall biosimilarity of MYL-1401O to the reference product, and extrapolation to all indications currently held by the reference product.
The FDA was supportive of the sponsor’s product, which was reflected in their presentation. The FDA concluded that extrapolation to all indications is supported by both the scientific understanding of the mechanism of action (MOA) and biosimilarity of MYL-1401O to the reference product. The FDA posed three discussion questions, which preceded the vote. The discussion focused on whether there was enough available evidence to support licensure of MYL-1401O for all approved indications of the reference product. The committee was largely in support, concluding that the analytical, pharmacological, and non-clinical evidence demonstrated biosimilarity and that there were no clinically meaningful differences between MYL-1401O and the US reference product. The vote, which asked members whether approval of MYL-1401O was appropriate for all indications, resulted in a 16-0 positive outcome.
Innovative Science Solutions (ISS) was proud to assist in providing regulatory insight and knowledge to Mylan throughout the FDA Advisory Committee Meeting process. ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org.
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us