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EMA Launching Pilot to Support Biosimilars Development
The European Union’s European Medicines Agency (EMA) is launching a tailored scientific advice pilot project in February 2017 to support step-by-step development of new biosimilars.
The procedure will advise biosimilar developers on the studies they should conduct, based on a review of the quality, analytical, and functional data they already have available. Standard advice does not include the assessment of existing data, the EMA states.
The pilot is expected to run until it has completed six scientific advice requests, with a maximum of one scientific advice request accepted per month. The program is available to all types of biosimilars, and includes a pre-submission meeting to review the suitability of the data package. The EMA advises biosimilar developers that the data package to be reviewed should be mature in order to fully benefit from the pilot. Data submitted should be directly related to the comparability exercise between the biosimilar and the reference medicinal product and statistical methods used for the comparison of quality data should be presented.
Applicants for the project should provide an overview of the full development plan and include questions related to quality development as well as questions related to the proposed nonclinical and/or clinical development so that the EMA’s Committee for Medicinal Products for Human Use (CHMP) can provide appropriate advice on the next steps of the development based on the quality data available.
The EMA’s Scientific Advice Working Party requires an extra month in addition to normal scientific advice timelines to review applications. A maximum of one Scientific Advice per month can be accepted.
Click here for a link to the EMA’s website showing an up-to-date list of the biosimilars approved in the EU.
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.
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.
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.
