First Herceptin Biosimilar Approved by FDA

After protecting their market exclusivity since 1998, Roche’s Genentech will now face competition from Mylan’s biosimilar version of Herceptin (trastuzumab), a biologic largely used to treat breast cancer. Ogivri has been approved by the US Food and Drug Administration (FDA) to treat HER2+ patients with breast or metastatic stomach cancer.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” said FDA Commissioner Scott Gottlieb. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”

Ogivri is only the second biosimilar drug approved by the FDA to treat cancer, and the first biosimilar indicated in breast cancer, specifically. Roche has fought hard to prevent biosimilar copycats of Herceptin from getting to market, most recently suing Pfizer for alleged patent infringement.

While the biosimilar was approved for all indications of the reference biologic, it was not approved as an interchangeable product. This means that patients will need to get a prescription for Ogivri from their doctors as pharmacists will be unable to automatically substitute prescriptions for Herceptin with the biosimilar.

Mylan cites its success in securing global licenses for Ogivri from Genentech and Roche this year as the primary reason behind its potential to be the first Herceptin biosimilar to market. Ogivri is currently under review by other regulatory bodies outside of the US, including the EMA in Europe and Health Canada.

“We are proud to receive FDA approval of Ogivri, a biosimilar to Herceptin, as this further underscores the strength of our science team and our ability to execute science programs for hard-to-make and complex products like biosimilars,” said Mylan President Rajiv Malik. “Bringing such complex products to the market not only requires sound and robust science and a talented research and development team, but also the ability to manage legal and regulatory complexities and invest significantly in manufacturing capabilities.”

Ogivri was co-developed by Mylan and Biocon, a biopharmaceutical company based in India.

“The US FDA’s approval for our biosimilar trastuzumab is indeed a crowning moment that puts us in an exclusive league of global biosimilar players,” said Kiran Mazumdar-Shaw, CMD Biocon. “It strengthens our resolve to focus on developing affordable biologics that can make cancer care both more effective and more equitable around the world. It is an important milestone in our journey of developing advanced therapies that have the potential to benefit billions of patients.”

This year, 250,000 new cases of breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed, up to 25 percent of which will be HER2+. Ogivri will be a biosimilar alternative to Herceptin, which brought in over $2 billion in US sales between September 2016 and September 2017.