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Biosimilar recombinant FSH
Biosimilar recombinant FSH is a Gonadotropin; Biosimilar Small molecule drug developed by IVI Madrid. It is currently FDA-approved for Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF), Anovulation and ovulatory disorders in women. Also known as: Bemfola.
Biosimilar recombinant FSH stimulates the growth and maturation of ovarian follicles by binding to and activating follicle-stimulating hormone receptors on granulosa cells.
Biosimilar recombinant FSH stimulates the growth and maturation of ovarian follicles by binding to and activating follicle-stimulating hormone receptors on granulosa cells. Used for Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF), Anovulation and ovulatory disorders in women.
At a glance
| Generic name | Biosimilar recombinant FSH |
|---|---|
| Also known as | Bemfola |
| Sponsor | IVI Madrid |
| Drug class | Gonadotropin; Biosimilar |
| Target | FSH receptor (FSHR) |
| Modality | Small molecule |
| Therapeutic area | Reproductive Medicine / Fertility |
| Phase | FDA-approved |
Mechanism of action
This biosimilar replicates the action of endogenous follicle-stimulating hormone (FSH), a gonadotropin that promotes follicular development in the ovary. By activating FSH receptors on ovarian granulosa cells, it increases estrogen production and facilitates the recruitment and maturation of multiple follicles, essential for assisted reproductive technologies. The biosimilar formulation is bioequivalent to the reference recombinant FSH product.
Approved indications
- Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF)
- Anovulation and ovulatory disorders in women
Common side effects
- Ovarian hyperstimulation syndrome (OHSS)
- Headache
- Injection site reactions
- Abdominal pain/discomfort
- Nausea
Key clinical trials
- An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
- Biosimilar Versus Urinary Gonadotropins (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Biosimilar recombinant FSH CI brief — competitive landscape report
- Biosimilar recombinant FSH updates RSS · CI watch RSS
- IVI Madrid portfolio CI
Frequently asked questions about Biosimilar recombinant FSH
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Related
- Drug class: All Gonadotropin; Biosimilar drugs
- Target: All drugs targeting FSH receptor (FSHR)
- Manufacturer: IVI Madrid — full pipeline
- Therapeutic area: All drugs in Reproductive Medicine / Fertility
- Indication: Drugs for Infertility in women undergoing assisted reproductive technology (ART) / in vitro fertilization (IVF)
- Indication: Drugs for Anovulation and ovulatory disorders in women
- Also known as: Bemfola
- Compare: Biosimilar recombinant FSH vs similar drugs
- Pricing: Biosimilar recombinant FSH cost, discount & access