European Medicines Agency (EMA) has published a draft guideline for r-hFSH which is open for public consultation and also the concept paper for the revision of the guideline on biosimilars.
The “draft guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human follicle stimulating hormone (r-hFSH)” is published on 24th of November on EMA’s homepage and is open for consultation till the end of May, 2012. This products-specific guideline presents the current view of the CHMP on the non-clinical and clinical requirements for demonstration of comparability of two r-hFSH containing medicinal products.
” Concept paper on the revision of the guideline on similar biological medicinal products” is also published on the same date and open for consultation till the end of February, 2012.
CHMP sees following items as problem statements and wants to update the “overarching” guideline with the contributions of interested parties:
– The principles of biosimilarity may have explained in a clearer way
– Numerous terms are in use for “biosimilar” or “similar biological medicinal product”, and often the term “biosimilar” has been used in an inappropriate way
– The feasibility to follow the generic legal basis for some biological products should be discussed
– Some more specific aspects require re-discussion and potentially a refinement.
You can reach both documents on EMA homepage, Public Consultations link.