Mylan has entered a global settlement with Genentech Inc and F. Hoffman-La Roche Ltd on a patent for trastuzumab (Herceptin), which will provide the company with global licenses for its trastuzumab biosimilar.
Under the global license, Mylan can now commercialize its product around the globe, except in Japan, Brazil, and Mexico. Today’s announcement ensures that the US market will see the first biosimilar to trastuzumab, once Mylan’s biologics license application—filed in collaboration with Biocon—is approved by the FDA. The Biosimilar User Fee Act for trastuzumab is September 3, 2017. The 2 companies have co-developed 5 other biologics.
“There is an unmet need for access to more affordable versions of biologic products such as trastuzumab. We look forward to enhancing access to this important treatment option, which complements our comprehensive cancer care offerings, in the U.S. and around the world,” said Heather Bresch, CEO of Mylan.
While Mylan has already been marketing the product in 14 emerging markets around the globe, the US and European markets would provide the most value—Roche reported sales of nearly $4.5 billion in 2016 alone. Just last week the New Delhi high court ruled in favor of Mylan being able to sell the trastuzumab biosimilar in India for additional indications using Roche’s package inserts for Herceptin.
BioRationality: EMA Accepts Waiver of Clinical Efficacy Testing of Biosimilars
April 21st 2025Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.