Mylan, Biocon move one step closer to challenging Roche's Herceptin

Look out, Roche--Herceptin copies are closer than ever.

On Tuesday, partners Mylan and Biocon announced that they had submitted an application for the breast cancer biosimilar version of the Roche cancer-fighter to the FDA. It’s the first submission for the team, which has a portfolio of meds still in clinical development.

The knockoff has already shown that it’s comparable to Herceptin when it comes to treating advanced HER2-positive breast cancer. In June at the American Society of Clinical Oncology annual meeting, it showed it could shrink tumors in 69.6% of patients, compared with the 64% that responded to Roche’s product.

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The pair is gunning for the chance to be the first Herceptin copycat to market--and therefore the first to take a swipe at the Roche drug’s blockbuster sales. Last year, Herceptin posted 15% growth in the U.S., with early and advanced breast cancer patients using the drug for longer in combination with newer oncology product Perjeta.

Unlike some of its big pharma peers, though, Roche has up-and-coming products to fill the gap if Herceptin does fall victim to competition. Its immuno-oncology treatment, Tecentriq, is approved in bladder cancer and lung cancer--an indication it just recently snagged. The Swiss drugmaker also boasts multiple sclerosis prospect ocrelizumab--to be marketed as Ocrevus--which is the first med to show it can be effective in the primary progressive form of the disease.