Mylan, Biocon File for FDA Approval of Herceptin Biosimilar

Roche’s cancer drug business could soon face some competition.

Mylan announced on Tuesday it submitted an application to the Food and Drug Administration for a proposed biosimilar of Herceptin to treat HER-2 positive breast and gastric cancers. Both companies believe this the first U.S. submission for a proposed biosimilar based off this drug.

Mylan and Biocon are collaborating on developing six biologic products, but this is the first submission to emerge from the partnership.

The filing contained a swath of study data demonstrating the biosimilar had comparable response rates to the original version when it came to treating breast cancer, according to FiercePharma. Results indicated the drug could shrink tumors in 69.6 percent of patients versus 64 percent with Roche’s rival product.

Other companies are developing biosimilar copies of Herceptin as well, reported FierceBiotech. South Korea’s Celltrion submitted an application for approval in Europe right after Mylan did while Allergan and Amgen posted positive phase 3 data for their version of the drug over the summer.

Roche’s pharmaceutical division posted 4 percent growth this year due to breast cancer drugs like Perjeta and Herceptin. Overall, the drug company generated $37.9 billion in the first nine months of 2016.

A slew of Herceptin biosimilars hitting the market could drive down prices, but FiercePharma noted treatments that Roche owns like immuno-oncology treatment Tecentriq and multiple sclerosis therapy ocrelizumab could cushion that blow.