The European Medicines Agency will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development of biosimilar medicines.
The European Medicines Agency (EMA) will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development of biosimilar medicines.
The EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical, and functional data they have already available for the product. This is designed to boost support the stepwise development of biosimilars that is recommended in European Union (EU) guidelines.
Biosimilars are biological medicines developed to be highly similar to another biological medicine (also known as the reference medicine) already authorized in the EU, according to an EMA statement. To obtain a marketing authorization, developers must establish similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy.
The pilot is open to all companies seeking scientific advice for the development of a biosimilar medicine. Any type of biosimilar will be accepted in the pilot, noted the EMA. Companies wishing 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.
The pilot is planned to run until six scientific advice requests have been completed, with maximum one scientific advice request accepted per month, the statement concluded.
For the original release click here
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.