- 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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.
