Mylan and Biocon's Ogivri Receives Positive CHMP Opinion

Mylan and Biocon’s biosimilar trastuzumab, which will be sold as Ogivri and which references Herceptin, today received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

“Obtaining a positive CHMP opinion for Ogivri is another significant achievement in Mylan’s continued efforts to bring more affordable medicines to the market,” said Mylan president Rajiv Malik. “The strong science and technology program behind this product has been instrumental in achieving this milestone and moving us one step closer to providing patients with this alternative option.”

The positive opinion is based on a package that includes analytical data as well as preclinical and clinical studies. The results from the studies found that there were no clinically meaningful differences in terms of quality, potency, and safety. Findings from the phase 3 Heritage clinical trial demonstrated that no clinically meaningful differences were present with respect to safety, efficacy, or immunogenicity when the biosimilar was compared with the reference.

Ogivri is indicated for the treatment of patients with human epidermal growth factor receptor 2—positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

The European Commission is expected to make a final decision regarding authorization by the end of 2018. Ogivri has already received regulatory approvals in 35 countries around the world, including the United States, where it earned FDA approval in 2017.

The product is not yet launched in the United States; while Mylan and Herceptin developer Roche reached a global settlement and license agreement in March 2017, it remains to be seen when the biosimilar will become available on the US market.

In looking to the future of the Mylan—Biocon partnership, Arun Chandavarkar, PhD, CEO and joint managing director of Biocon, said, “We shall continue to execute on our biosimilars strategy of expanding affordable access to high quality products targeting critical illnesses like cancer.”