The U.S. Food and Drug Administration (FDA) has approved the first biosimilar for the treatment of HER2-positive breast cancer in 20 years, as announced on December 15, 2017. The biosimilar, MYL-1401, also known as Ogivri, manufactured by Mylan and Biocon, is an alternative to Roche's Herceptin (trastuzumab), a blockbuster cancer drug. Ogivri is approved for all indications of Herceptin, including HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
The approval of Ogivri is based on a comprehensive analytical, nonclinical, and clinical data package, including results from the HERITAGE study, which demonstrated clinical equivalence between Ogivri and Herceptin. This marks the fifth biosimilar approved in the U.S. in 2017 and is Mylan's second biosimilar approved by the FDA this year. It is also the first biosimilar approved in the U.S. for a cancer indication.
The introduction of biosimilars like Ogivri is expected to increase patient access to biological treatments and potentially reduce healthcare costs, aligning with Mylan's mission to provide access to high quality medicine. The market for trastuzumab biosimilars is set to intensify, particularly in Europe where Ogivri was approved earlier in 2017 and is already launching. Further details regarding the U.S. launch are expected soon.
