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.

Conference

The 13th Annual Digital Pharma East

Digital Pharma East returns to the Pennsylvania Convention Center September 17–20, bringing together over 1000 attendees from biotech and pharma, to better understand how to present business plans, justify budget and innovation, and de-risk proposals getting shut down — essentially, understand how they can return to the office and become champions for their internal digital needs. Join us and save 15% on standard rates when you register with Discount Code DPE19Fierce.

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.

Suggested Articles

For just the second time, the DOJ indicted an opioid distributor for its role in illegally pushing pills at the height of the addiction epidemic.

Bristol-Myers Squibb is out to expand the pool of colorectal cancer patients it can treat with Opdivo—and it’s bringing in Bayer to help.

When AstraZeneca sold its Avlon, England plant in 2016, it thought its liabilities were over. Former employees said the drugmaker broke its promises.