Decision slated for early September.
The US FDA will decide whether to approve Biocon and Mylan’s version of the Roche breast cancer drug Herceptin by the beginning of September, as reported by BioPharm Reporter.
Indian drugmakers Biocon and Mylan, which are developing six biosimilar monoclonal antibodies for global markets, announced today their first US submission has been accepted for review by the US Food and Drug Administration (FDA).
The biologics license application (BLA) for the proposed biosimilar version of Roche/Genetech’s Herceptin (trastuzumab) was filed through the 351(k) pathway and the Agency has given the date of September 3, 2017 as its decision date as to whether or not it is to be approved.
MYL-1401O was submitted to the Agency in November, and if approved the two companies say it will be the first biosimilar to challenge Herceptin in the US.
“We believe that our comprehensive package of analytical similarity, non-clinical and clinical data submitted with the BLA will demonstrate similarity of the proposed biosimilar trastuzumab to the reference product,” Mylan’s president Rajiv Malik said in a statement.
Biocon CEO Arun Chandavarkar added: “This development positions Biocon and Mylan among the first companies to be able to address the critical need of U.S. patients for a high-quality biosimilar to treat certain HER2-positive breast cancers, in the near future.”
The biosimilar trastuzumab is also under review by the European Medicines Agency (EMA).
Source: BioPharm Reporter
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.
Annual STADA Report Shows Record Profit Growth for 2023
March 25th 2024Germany-based biosimilar manufacturer STADA Arzneimittel reports strong financial performance in 2023 with double digit sales growth and billions in profits. The CEO credits the company’s success on their strong company culture and focus for innovation.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Physician and Patient Perspectives After Starting or Switching to Amgevita in IBD
March 23rd 2024A real-world study surveying physicians and patients on adalimumab biosimilar ABP 501 (Amgevita) in inflammatory bowel disease (IBD) found both patients initiating ABP 501 and those who had switched from the reference product had higher satisfaction levels.