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Ovaleap
Published
Product name
Ovaleap
Active ingredient
Follitropin alfa
Submission type
New biosimilar medicine
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Ovaleap (follitropin alfa) was approved for the following therapeutic use:
- The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated.
- For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies.
- Ovaleap is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.
How this medicine works
Ovaleap (follitropin alfa) is a biosimilar medicine to Gonal-f (follitropin alfa) solution for injection.In females, the most important effect resulting from parenteral administration of follicle stimulating hormone (FSH) is the development of mature Graafian follicles. To complete follicular maturation and to stimulate ovulation in the absence of an endogenous luteinising hormone (LH) surge, human chorionic gonadotropin (hCG) is given once monitoring of the patient indicates that sufficient follicular development has occurred. There may be a degree of inter-patient variability in response to FSH administration, with lack of response to FSH in some patients. In males, FSH stimulates spermatogenesis without significant effect on the androgen secreting interstitial cells.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology) and clinical (pharmacology, safety and efficacy) information submitted by the sponsor. The benefit-risk profile of Ovaleap was considered favourable for the therapeutic use approved.
Sponsor