Mylan N.V. and Biocon Ltd. announced that the FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies' proposed biosimilar trastuzumab.

Mylan N.V. and Biocon Ltd. announced that the FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies' proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings.

Data presented to ODAC included results from analytical, nonclinical and clinical studies which demonstrated that the proposed biosimilar trastuzumab is highly similar to Herceptin, in line with the FDA assessment provided in the pre-meeting briefing documents. ODAC determined that no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. As such, the committee concluded that the totality of evidence supports a recommendation for FDA approval.

Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Comment: Mylan N.V. has agreed to the terms of a global settlement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licenses for its trastuzumab product. The global license will provide a clear pathway for Mylan to commercialize its trastuzumab product in various markets around the world, commencing on the license effective dates, which are confidential. The licenses pertain to all countries except Japan, Brazil and Mexico.