- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
US FDA Accepts Mylan Biologics License Application (BLA)
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
The Top 5 Most-Read Conference Articles of 2024
December 26th 2024The top 5 biosimilar conference articles in 2024 highlight significant progress in the biosimilar landscape, including strategies for market sustainability, safety of switching to biosimilars, and substantial savings through high biosimilar adoption, while also addressing ongoing challenges.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Top 5 Most-Read Oncology Articles of 2024
December 24th 2024The top 5 oncology biosimilar articles in 2024 cover Duke's recommendations for cell and gene therapy biosimilars, FDA approval of Shanghai Henlius Biotech's trastuzumab biosimilar, Boehringer Ingelheim layoffs, the safety of rituximab biosimilar CT-P10, and more.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Top 5 Most-Read Legal Articles of 2024
December 23rd 2024The top legal stories in biosimilars from 2024 emphasize the ongoing struggle between ensuring timely patient access and addressing challenges like litigation, regulatory hurdles, and patent disputes that shape the competitive landscape of affordable biologics.
Empowering Vulnerable Populations: The Path to Equitable Biologic Therapy Access
December 22nd 2024Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discusses strategies to improve equitable access to biologic therapies, including tiered formularies, income-based cost sharing, patient assistance programs, and fostering payer partnerships.
