- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Mylan's Settlement With Genentech and Roche Opens US Market for Trastuzumab Biosimilar
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.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
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?
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.
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.
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.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
