Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Mylan, Genentech and Roche Reach Agreement on Biosimilar Cancer Drug



The global license will allow Mylan to market its trastuzumab product in multiple countries around the world, excluding Brazil, Mexico and Japan.

Share this!

March 15, 2017 | by Sarah Hand, M.Sc.

Mylan’s biosimilar version of the breast cancer drug, Herceptin, may soon be available, thanks to a settlement reached between the pharmaceutical company and the makers of the reference biologic, Genentech and Roche. The global license will allow Mylan to market its trastuzumab product in multiple countries around the world, excluding Brazil, Mexico and Japan.

A condition of the agreement required Mylan to drop two patent litigation cases against Genentech, regarding Herceptin. Mylan has already submitted an application for the Herceptin biosimilar to the US Food and Drug Administration (FDA), and the company hopes to be the first to introduce the trastuzumab drug to the US market.

“There is an unmet need for access to more affordable versions of biologic products such as trastuzumab,” said Heather Bresch, CEO of Mylan. “We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the US and around the world.”

Mylan is developing trastuzumab alongside Biocon, along with five other biologic products. While Mylan has sole commercialization rights for the biosimilar in the US, Canada, Japan, Australia, New Zealand and in the European Union, Biocon will work alongside Mylan to commercialize the cancer treatment in the rest of the world.

Mylan is also awaiting European Medicines Agency (EMA) approval for trastuzumab. Currently, the biosimilar is sold in 14 emerging markets around the world.

“With 16 biosimilar products in development,” said Bresch, “we believe Mylan has one of the industry's broadest portfolios of biosimilars and that we will be a leader in bringing high-quality biosimilar products to market given our ability not only to develop and manufacture such complex products, but also to navigate the intricate regulatory and legal environment and successfully commercialize these products on a global basis.”

In 2016, sales of Herceptin reached nearly $4.5 billion in the US and European markets. In addition to its pending regulatory submission for trastuzumab, Mylan and Biocon have also applied for approval for their biosimilar of Amgen’s Neulasta.

Keywords: Biosimilar, Breast Cancer, Biologic


Share this with your colleagues!

Use of Testosterone Treatments Boosted by DTC Ad Campaigns

March 24, 2017 - Those with a stake in the pharmaceutical industry often question the effectiveness of direct-to-consumer (DTC) advertising, and whether it truly influences consumers to talk to their doctors about medical conditions and perhaps even ask for drugs by name.

Featured In: Pharmaceutical Marketing News

FDA Approves New Drug for Parkinson’s Disease

March 23, 2017 - Newron Pharmaceuticals’ Xadago (safinamide) has been approved by the US Food and Drug Administration (FDA) as an add-on medication for patients with Parkinson’s disease.

Featured In: Clinical Trials News, Life Science News, Pharmaceutical News

Amgen Identifies Issue with Patient Access to PCSK9 Inhibitor

March 23, 2017 - Most US patients hoping to get their PCSK9 inhibitor medications covered by their prescription drug plan are being denied, according to two new studied conducted by Amgen.

Featured In: Biotech News


Will Pharmaceutical Serialization Solve All of Our Drug Counterfeiting Problems?


How to Improve the Speed and Efficiency of Your Clinical Trials

High Performance Computing for High Content Screening - A Case Study

The FDA Guidance on the Assessment of Abuse Potential of Drug – A Critical Review

Treatment of Psoriasis: Improvements Through Clinical Trials

Copyright © 2016-2017 Honeycomb Worldwide Inc.