Follitropin alfa biosimilar - GEMAAlternative Names: Folitime; r-hFSH biosimilar - GEMA; recombinant humanfollicle stimulating hormone - GEMA
Latest Information Update: 08 Mar 2017
At a glance
- Originator GEMA
- Class Follicle stimulating hormones; Infertility therapies; Peptide fragments; Pituitary gonadotropins; Recombinant proteins
- Mechanism of Action Ovarian follicle stimulants
Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
On Fast track
Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.
- New Molecular Entity No
Highest Development Phases
- Phase III Female infertility
Most Recent Events
- 01 Dec 2016 GEMA completes a phase III trial in Female infertility in Argentina (SC) (NCT02454556)
- 01 Apr 2015 Phase-III clinical trials in Female infertility in Argentina (SC)