AFOLIA r-hFSH biosimilar for IVF
Product
AFOLIA is a recombinant-human Follicle-Stimulating Hormone (r-hFSH) and is being developed as a biosimilar to Gonal-f®, an already-marketed established reference product
Indication
r-hFSH is mainly used to stimulate the ovaries in the context of treatment for infertility
Stage of development
AFOLIA is being developed according to EMA biosimilar guidelines and FDA requirements for the 505b2 pathway
| Development | Pre-Clinics | Phase-I | Phase-III | Submission | Approval | |
| Europe | done | done | done | in finalization | in preparation | expected 2013 |
| USA | done | done | done | in preparation | -- | expected 2015 |
See: clinicaltrials.gov
