Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.
Posted 16 December 2016 | By Zachary Brennan
The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars.
The tailored procedure will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available (standard scientific advice does not include the assessment of existing data).
EMA plans to run the pilot until it has completed six scientific advice requests, with maximum of one scientific advice request accepted per month. The agency will analyze the outcome of the pilot after its completion.
The pilot will be open to all types of biosimilars and includes a pre-submission meeting to review the suitability of the data package. EMA also says that applicants should note that the agency’s Scientific Advice Working Party will need an extra month in addition to normal scientific advice timelines to review applications for the pilot.
In terms of what should be submitted, applicants are expected to provide an overview of the full development plan and include questions not only related to the quality development but also to the proposed non-clinical and/or clinical development, thus allowing EMA’s Committee for Medicinal Products for Human Use (CHMP) to provide appropriate advice on the next steps of the development (quality, non-clinical, clinical) based on the quality data available.
But EMA notes that questions on quality issues unrelated to the comparability between the biosimilar and reference product are outside the scope of the pilot and can be submitted separately using the normal scientific advice procedure.
For any information regarding the pilot please contact ScientificAdvice@ema.europa.eu.
Tailored scientific advice to support step-by-step development of new biosimilars
Tags: biosimilars, biosimilar scientific advice, biosimilar data