Follitropin alfa biosimilars
A fertility hormone used to stimulate the ovaries in IVF, with two European biosimilars, none in the United States, and three Indian makers.
About follitropin alfa
Follitropin alfa is manufactured follicle-stimulating hormone, the hormone that makes eggs mature in the ovary. In fertility treatment it is used to grow several eggs at once before they are collected.
It acts on the cells surrounding each egg and drives the follicles to grow. In men it supports sperm production. Its sugar chains determine how long it lasts and how strongly it works, which is the hardest part to copy.
A daily injection under the skin during the stimulation phase of fertility treatment, from a multi-dose pen or single-dose syringes, with the dose adjusted to the ovary's response.
Women who do not ovulate, ovarian stimulation for IVF, and some forms of hormone deficiency in women and men.
A biosimilar is compared in the laboratory, especially its sugar chains, in volunteers whose own hormones are suppressed, and in a clinical study in women having IVF, where the number of eggs collected is the measure.
The reference product is Gonal-f, from Merck. It was one of the first medicines approved centrally in Europe.
Follitropin is a fertility market where biosimilars are established in Europe and absent in the United States, and where the clinical study is compact. India has three domestic makers and a large IVF sector, and one European biosimilar is registered in the Gulf.
Clinical details are summarised from the reference product's prescribing information. Approval dates, numbers and presentations are in the tables below, each with its source.
Competitive outlook
- Todayfive follitropin alfa biosimilars are approved in at least one of the seven markets.
- Nearest to marketQL1012 has reached phase 3, the last trial before a filing.
- If all of them arriveThe approved count would rise from five to six.
No published switching study for this molecule yet.
Approvals by year
Regulatory register
| Regulator | Brand | Holder or applicant | Approved | Application or permission | US licence | Status | Source |
|---|---|---|---|---|---|---|---|
| EMA | Ovaleap | Theramex Ireland Limited | Sep 2013 | EMEA/H/C/002608 | Approved | S017 | |
| EMA | Bemfola | Gedeon Richter Plc. | Mar 2014 | EMEA/H/C/002615 | Approved | S017 | |
| MHRA | Bemfola | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Ovaleap | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| CDSCO | Reliance Life Sciences (INN only) | Reliance Life Sciences Pvt Ltd | Apr 2010 | MF-436/10 | Approved | S014 | |
| CDSCO | Intas Biopharmaceuticals (INN only) | Intas Biopharmaceuticals Ltd | May 2013 | MF-99/2013 | Approved | S014 | |
| CDSCO | Cadila Healthcare (INN only) | Cadila Healthcare Ltd | Jan 2018 | MF-208/2017 | Approved | S014 | |
| EDE | Bemfola | Gedeon Richter Plc., Hungary | Sep 2016 | not published | Registered | S018 |
Last checked Sep 2026. US interchangeability designations are listed in full on the interchangeable biosimilars page. CDSCO lists permissions by firm and INN, not brand. PMDA's list and the UAE directory do not publish application numbers; Canadian dates are the first approval or market date recorded in the Drug Product Database.
Regulatory pathway by market
Requirements for a follitropin alfa biosimilar under the guidance in force in September 2026.
| FDA, United States | EMA, European Union | MHRA, United Kingdom | PMDA, Japan | Health Canada | CDSCO, India | EDE, UAE | |
|---|---|---|---|---|---|---|---|
| Legal pathway | Section 351(k), open since 23 March 2020 when follitropin NDAs became biologics licences; no follitropin has yet been approved under it | Article 10(4) of Directive 2001/83/EC; centralised procedure is mandatory for biotechnology products | UK marketing authorisation from MHRA. EU approvals in force at the end of 2020 became Great Britain licences automatically; new products since 2021 are approved through reliance on EMA or FDA decisions, and from 2024 through the International Recognition Procedure. Northern Ireland follows EU licences | MHLW approval on PMDA review under the Guideline for Ensuring Quality, Safety and Efficacy of Biosimilars (2009, revised 2020), with Q&A updates in 2024 and 2026 | Notice of Compliance under the Food and Drug Regulations as a biosimilar biologic drug, assessed under Health Canada's guidance on biosimilars (2016, revised 2022 and 2026) | Guidelines on Similar Biologics (CDSCO and DBT, 2016, in force); revised draft published May 2025 | Registration through the Emirates Drug Establishment; the public directory does not distinguish biosimilars from other biologicals |
| Reference product | US-licensed reference; a non-US comparator may be used with analytical and PK bridging | EU-authorised reference; a non-EEA comparator may be used with bridging data | Reference biologic authorised in the UK, or an EU-authorised version with bridging data | The original biopharmaceutical approved in Japan; foreign-sourced reference accepted with bridging since the 2020 revision | Reference biologic drug authorised in Canada, or a non-Canadian version of it with bridging data | Product licensed in India, or if not, one licensed in an ICH country, with justification | Not stated in the public directory; registration relies on assessment by reference regulators |
| Comparative clinical study | Draft guidance (October 2025): comparative analytical assessment plus a PK similarity study and immunogenicity assessment; a comparative efficacy study is generally not needed | Reflection paper adopted March 2026: a comparative efficacy trial can be waived when analytical and PK comparability is sufficient | Follows the EU guideline; MHRA's 2021 biosimilar guidance states that a comparative efficacy trial is generally not needed where analytical and pharmacokinetic comparability is shown | Comparative PK study and, in principle, a comparative efficacy study; the May 2026 early consideration sets out when the efficacy study can be omitted, and Japanese patient data are no longer required in every case (2025) | Comparative structural and functional studies, PK and, where warranted, PD equivalence; the 2026 revision reduces the expectation of comparative efficacy trials in line with FDA and EMA | Comparative PK/PD study and a comparative safety and efficacy study are generally expected, followed by a post-marketing study | Assessed on the dossier accepted by the reference regulator |
| Interchangeability | A separate designation permitting pharmacy-level substitution; switching studies generally not required under the June 2024 draft | EMA and HMA statement (September 2022): EU biosimilars are interchangeable with their reference; substitution rules are set by each member state | No designation; MHRA considers approved biosimilars interchangeable with their reference, and switching is decided by the prescriber and by NHS commissioning | Not defined; prescribing by brand, with pharmacist substitution not automatic | No federal designation; substitution and mandatory switching policies are set by each province, several of which have required switching since 2019 | Not defined in the guidelines | Not defined |
| Naming | INN plus a four-letter suffix | INN, identical to the reference; brand name and batch recorded for pharmacovigilance | Brand name with the non-proprietary name; licence numbers PL, PLGB or PLNI | INN followed by BS (biosimilar), strength, form and the company name in quotation marks, with a biosimilar number in the non-proprietary name | Non-proprietary name identical to the reference, with brand name and DIN as identifiers | INN with the brand name | Brand name as registered |
Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs; MHRA guidance on the licensing of biosimilar products (2021).
EvySaif prepares the comparative evidence plan and the regional dossier strategy for follitropin alfa programmes. Regulatory strategy consulting
Presentations and concentration
Multi-dose pens of 300 IU/0.5 mL, 450 IU/0.75 mL and 900 IU/1.5 mL, and single-dose syringes of 75 to 450 IU (Bemfola).
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Ovaleap XM17 | · | see SmPC | 300, 450 and 900 IU | · | · | · | · |
| Bemfola | · | see SmPC | 75 to 450 IU pens | · | · | · | 75, 150, 225, 300 and 450 IU pens |
| Reliance Life Sciences follitropin alfa | · | · | · | · | · | Injection | · |
| Intas follitropin alfa | · | · | · | · | · | Injection | · |
| Zydus follitropin alfa | · | · | · | · | · | Injection | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Teva (BioGeneriX) | Ovaleap | · | ✓ | ✓ | · | · | · | · |
| Finox Biotech | Bemfola | · | ✓ | ✓ | · | · | · | ✓ |
| Reliance Life Sciences | Reliance Life Sciences follitropin alfa | · | · | · | · | · | ✓ | · |
| Intas Pharmaceuticals | Intas follitropin alfa | · | · | · | · | · | ✓ | · |
| Cadila Healthcare (Zydus Lifesciences) | Zydus follitropin alfa | · | · | · | · | · | ✓ | · |
Entering a market where a competitor is already listed changes the evidence and pricing conversation. EvySaif's global value dossier and HTA submission work covers that side.
Products
Ovaleap
Bemfola
Reliance Life Sciences follitropin alfa
Intas follitropin alfa
Zydus follitropin alfa
In development
ClinicalTrials.gov holds one comparative trial of one follitropin alfa biosimilar candidate against the reference product, run by one sponsor. None of the candidates (QL1012) has an approval yet in any of the seven markets. Trials are listed with the sponsor's own wording for status and dates.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|
| QL1012 | Qilu Pharmaceutical | Gonal-f | Phase 3 | Comparative efficacy | Completed | Oct 2018 | Oct 2019 | no approval in the seven markets | NCT05149924 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026. The full list across all molecules is on the pipeline page.
Questions
Is there a follitropin alfa biosimilar in the United States?
No. Neither European biosimilar has sought US approval.
Which follitropin alfa biosimilars are approved in Europe?
Ovaleap, since 2013, and Bemfola, since 2014.
Is there a follitropin alfa biosimilar in India?
Yes, three: Reliance, Intas and Zydus hold manufacturing permissions.
Which follitropin alfa biosimilars are registered in the UAE?
Bemfola, alongside Gonal-f.
How is a follitropin alfa biosimilar tested?
Laboratory comparison of the sugar chains, a volunteer study, and a clinical study in women having IVF counting the eggs collected.
Is follitropin beta a biosimilar of follitropin alfa?
No. It is a different originator product from another company, made by a different process.
Work with EvySaif on follitropin alfa
Follitropin alfa biosimilar landscape report
The register on this page as a delivered document: every approval, holder, presentation and pathway requirement across FDA, EMA, CDSCO and the Gulf, updated to the month, with the sources attached.
Request the landscape reportRegulatory gap assessment
For a developer deciding whether and where to file: a review of your analytical, PK and clinical package against what each regulator expects for follitropin alfa, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)S009CDSCO and DBT, Guidelines on Similar Biologics 2016 Primary (regulator)S010CDSCO, Draft Guidelines on Similar Biologics 2025 Primary (regulator)S024ClinicalTrials.gov, study records (API v2, one query per molecule with the term biosimilar) Registry (sponsor-entered)
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