- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
EMA Plans Pilot for Biosimilars Developers
Breadth and depth of established data will determine study approach.
In February 2017, the European Medicines Agency (EMA) plans to test the added value and feasibility of tailored scientific advice for the development of biosimilar medicines.
The pilot is open to all companies seeking scientific advice for the development of a biosimilar medicine, and planned to run until six scientific advice requests have been completed, with maximum one scientific advice request accepted per month, per the EMA's public statement. The objective of the pilot is to give developers of biosimilars advice for conducting studies/tests based upon qualitative, analytical, and functional data already available for the product, and to support the recommended biosimilars development within European Union (EU) guidelines.
Per the EMA, any type of biosimilar will be accepted in the pilot.
Companies that would like to take part in the pilot will have a pre-submission meeting during which the suitability of the data package is reviewed. The EMA’s Scientific Advice Working Party will need an extra month in addition to normal scientific advice timelines to review the requests accepted in the pilot.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.
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.
Patient Perceptions of Switching From the Reference Adalimumab to Amjevita During Its Initial Launch
April 20th 2024In a survey of patients with autoimmune arthritis who had been switched from reference adalimumab (Humira) to biosimilar adalimumab-atto (Amjevita; Amgen), most reported preferring the biosimilar and had no concerns about switching.
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.
