The new draft guideline will replace the ‘Guidance on similar medicinal products containing recombinant human soluble insulin’ (EMEA/CHMP/BMWP/32775/2005), which came into effect in June 2006. The new draft guideline lays down the non-clinical and clinical requirements for recombinant insulin-containing biosimilars, including human insulin and insulin analogues (both referred to as insulin).

Draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues EMEA/CHMP/BMWP/32775/2005 Rev. 2
Released for consultation: 30 April 2014
End of consultation: 31 July 2014
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/04/WC500165988.pdf

The non-clinical section addresses the requirements of in vitro pharmacodynamic studies and cases when there is a need for additional in vivo toxicological assessment. The clinical section addresses the requirements for pharmacokinetic, pharmacodynamic and safety studies as well as the risk management plan. Requirements for insulin-clamp studies (used to measure how patients metabolize glucose or how sensitive patients are to insulin) and for long-acting insulin preparations are also included.

The draft guideline also makes it clear that there is no anticipated need for specific efficacy studies since endpoints used in such studies, usually HbA1c (glycated haemoglobin), are not considered sensitive enough for the purpose of showing biosimilarity of two insulins. Clarity is also provided on extrapolation of indications, e.g. from subcutaneous to intravenous use and to other indications and patient populations licensed for the reference product.

Feedback on the draft guideline can be submitted to bmwp.secretariat@ema.europa.eu until 31 July 2014. EMA does not state when it expects a finalized guideline to be ready.

Related article

EU guidelines for biosimilars

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2014 Pro Pharma Communications International. All Rights Reserved.