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.
Competitive Pricing in Biosimilars: How Adalimumab Could Shape the Industry
Published: October 29th 2024 | Updated: October 29th 2024Sophia Humphreys, PharmD, MHA, BCBBS, of Sutter Health notes that although initial adoption of adalimumab biosimilars remained low in 2023, competitive pricing pressures have already benefited patients and the health care sector.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Calling for Unified Biosimilar Standards, Stronger Education at GRx+Biosims
October 23rd 2024At the GRx+Biosims conference, a fireside chat highlighted the need to streamline biosimilar development and strengthen industry collaboration, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.