Mylan Clears Runway For US Herceptin Biosimilar Launch
The generic drug manufacturer is poised to be first to market with a biosimilar version of Roche’s blockbuster breast cancer therapy after reaching a license agreement. The date of a potential launch remains confidential.
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The generic drug company will drive mid-term growth by investing in high-barrier-to-entry generics and biosimilars while diversifying into brand medicines and over-the-counter drugs. Management presented a strategy overview during an investor day March 1.
At least five biosimilars could gain US licensure in the coming year on first-cycle review, including subsequent competitors to Remicade and Humira; however, patent litigation is expected to increase and will continue to slow the march of products from FDA approval to commercialization.
Following advice of Solicitor General, high court grants both Sandoz and Amgen Zarxio petitions challenging Federal Circuit’s interpretation of the biosimilars statute.