Teriparatide biosimilars
A daily injection that builds bone in severe osteoporosis, with six European biosimilars, four Indian makers since 2010, and no US biosimilar because the United States treats it as a drug.
About teriparatide
Teriparatide is a fragment of parathyroid hormone. Given as a brief daily pulse it stimulates the cells that build bone, which is the opposite of what most osteoporosis drugs do. It is used in people at high risk of fracture.
A short daily burst of the hormone tells bone-building cells to work harder. Continuous exposure would do the opposite, so the once-daily injection pattern is essential.
One injection under the skin each day from a multi-dose pen, for up to two years.
Osteoporosis in women after the menopause and in men at high risk of fracture, and osteoporosis caused by steroid treatment.
Teriparatide is a small peptide, and in Europe a biosimilar is compared in the laboratory and in healthy volunteers by measuring blood calcium. No clinical trial in patients has been required.
The reference product is Forsteo in Europe and Forteo in the United States, from Eli Lilly. Because teriparatide is a small peptide, the United States classes it as a drug rather than a biologic, so American copies are generics, not biosimilars.
Teriparatide is a product whose status changes at the border: a biosimilar in Europe and India, a generic drug in the United States. India was first, with Intas in 2010, and Indian and Iranian companies now hold half of the European approvals.
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
- Todaysixteen teriparatide biosimilars are approved in at least one of the seven markets.
- AheadNo further candidate is visible in comparative trials or under review, so the competitive set is the approved products in the register below.
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 | Terrosa | Gedeon Richter Plc. | Jan 2017 | EMEA/H/C/003916 | Approved | S017 | |
| EMA | Movymia | STADA Arzneimittel AG | Jan 2017 | EMEA/H/C/004368 | Approved | S017 | |
| EMA | Livogiva | Theramex Ireland Limited | Aug 2020 | EMEA/H/C/005087 | Approved | S017 | |
| EMA | Qutavina | EuroGenerics Holdings B.V. | Aug 2020 | EMEA/H/C/005388 | Withdrawn | S017 | |
| EMA | Sondelbay | Accord Healthcare S.L.U. | Mar 2022 | EMEA/H/C/005827 | Approved | S017 | |
| EMA | Kauliv | Strides Pharma (Cyprus) Limited | Jan 2023 | EMEA/H/C/004932 | Approved | S017 | |
| EMA | Zandoriah | CinnaGen Co Unipessoal LDA | Apr 2026 | EMEA/H/C/006688 | Approved | S017 | |
| MHRA | Kauliv | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Movymia | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Terrosa | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Sondelbay | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Lusama | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Teriparatide Teva | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Teriparatide Sun | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Teriparatide Dr. Reddy's | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Teriparatide Biotech | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| MHRA | Teriparatide Ambio Pharma | Not shown in the MHRA substance list | not shown | not published | Approved | S023 | |
| PMDA | Teriparatide BS MOCHIDA | Mochida Pharmaceutical | Sep 2019 | not published | Approved | S020 | |
| HC | Osnuvo | Avir Pharma INC. | Jan 2020 | DIN 02495589 | Approved | S022 | |
| CDSCO | Intas Biopharmaceuticals (INN only) | Intas Biopharmaceuticals Ltd | Nov 2010 | MF-893/10 | Approved | S014 | |
| CDSCO | USV (INN only) | USV Limited | Aug 2012 | MF-179/2012 | Approved | S014 | |
| CDSCO | Cadila Healthcare (INN only) | Cadila Healthcare Ltd | Aug 2012 | MF-207/2012 | Approved | S014 | |
| CDSCO | Enzene Biosciences (INN only) | Enzene Biosciences Limited | Jan 2021 | MF/BIO/21/000014 | Approved | S011 |
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 teriparatide 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 | Not available: teriparatide is a 34-amino-acid peptide regulated as a drug in the United States, so follow-on products use the 505(b)(2) or ANDA routes, not 351(k) | 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 | Not applicable under 351(k); 505(b)(2) products relied on pharmacokinetic and pharmacodynamic bridging to Forteo | 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 | Not applicable; a generic approved by ANDA is substitutable as a drug | 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 | Teriparatide, as a drug, without a biologic 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 teriparatide programmes. Regulatory strategy consulting
Presentations and concentration
The standard presentation is a 600 microgram in 2.4 mL pre-filled pen (250 micrograms/mL) delivering 20 micrograms per dose. Indian products also use 750 microgram cartridges and vials.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Terrosa / Movymia RGB-10 | · | see SmPC | 20 micrograms/80 microlitres | · | · | · | · |
| Livogiva | · | see SmPC | · | · | · | · | · |
| Sondelbay / Intas teriparatide | · | see SmPC | 20 micrograms/80 microlitres | · | · | 750 micrograms in 3 mL pre-filled cartridge | · |
| Kauliv | · | see SmPC | 20 micrograms/80 microlitres | · | · | · | · |
| Zandoriah | · | see SmPC | · | · | · | · | · |
| USV teriparatide | · | · | · | · | · | 750 micrograms in 3 mL vial | · |
| Zydus teriparatide | · | · | · | · | · | Vial and cartridge | · |
| Enzene Biosciences teriparatide | · | · | · | · | · | 600 micrograms/2.4 mL pen; 750 micrograms/3 mL | · |
| Teriparatide BS Mochida | · | · | · | 600 microgram subcutaneous kit | · | · | · |
| Osnuvo | · | · | · | · | 250 micrograms | · | · |
| Lusama | · | · | 20 micrograms/80 microlitres pen | · | · | · | · |
| Teriparatide Teva | · | · | 20 micrograms/80 microlitres pen | · | · | · | · |
| Teriparatide Sun | · | · | 20 micrograms/80 microlitres pen | · | · | · | · |
| Teriparatide Dr. Reddy's | · | · | 20 micrograms/80 microlitres pen | · | · | · | · |
| Teriparatide Biotech | · | · | 20 micrograms/80 microlitres pen | · | · | · | · |
| Teriparatide Ambio Pharma | · | · | 20 micrograms/80 microlitres pen | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Richter-Helm BioTec and Gedeon Richter | Terrosa / Movymia | · | ✓ | ✓ | · | · | · | · |
| Not stated in the EMA table | Livogiva | · | ✓ | · | · | · | · | · |
| Intas Pharmaceuticals | Sondelbay / Intas teriparatide | · | ✓ | ✓ | · | · | ✓ | · |
| Strides Pharma | Kauliv | · | ✓ | ✓ | · | · | · | · |
| CinnaGen | Zandoriah | · | ✓ | · | · | · | · | · |
| USV | USV teriparatide | · | · | · | · | · | ✓ | · |
| Cadila Healthcare (Zydus Lifesciences) | Zydus teriparatide | · | · | · | · | · | ✓ | · |
| Enzene Biosciences (Alkem) | Enzene Biosciences teriparatide | · | · | · | · | · | ✓ | · |
| Mochida Pharmaceutical | Teriparatide BS Mochida | · | · | · | ✓ | · | · | · |
| Avir Pharma | Osnuvo | · | · | · | · | ✓ | · | · |
| Not stated in the MHRA list | Lusama | · | · | ✓ | · | · | · | · |
| Teva | Teriparatide Teva | · | · | ✓ | · | · | · | · |
| Sun Pharmaceutical Industries | Teriparatide Sun | · | · | ✓ | · | · | · | · |
| Dr. Reddy's Laboratories | Teriparatide Dr. Reddy's | · | · | ✓ | · | · | · | · |
| Not stated in the MHRA list | Teriparatide Biotech | · | · | ✓ | · | · | · | · |
| Not stated in the MHRA list | Teriparatide Ambio Pharma | · | · | ✓ | · | · | · | · |
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
Terrosa / Movymia
Livogiva
Sondelbay / Intas teriparatide
Kauliv
Zandoriah
USV teriparatide
Zydus teriparatide
Enzene Biosciences teriparatide
Teriparatide BS Mochida
Osnuvo
Lusama
Teriparatide Teva
Teriparatide Sun
Teriparatide Dr. Reddy's
Teriparatide Biotech
Teriparatide Ambio Pharma
In development
No comparative trial of a teriparatide biosimilar candidate against the reference product was found on ClinicalTrials.gov with the word biosimilar in the record. That does not mean nothing is in development: programmes registered only on national registries, or under a code without the word, are not captured. See the pipeline page for how the list is built.
Questions
Why is there no teriparatide biosimilar in the United States?
Teriparatide is a short peptide and stayed classed as a drug when other proteins became biologics in 2020. American copies were approved as generics.
Which was the first teriparatide biosimilar?
Intas's product in India in 2010. Europe's first, Terrosa and Movymia, came in 2017.
Is there a teriparatide biosimilar in the UAE?
Not yet. Forteo is registered.
How is a teriparatide biosimilar tested in Europe?
Laboratory comparison and a volunteer study measuring blood calcium. No patient trial has been required.
Which companies make teriparatide in India?
Intas, USV, Zydus and Enzene hold manufacturing permissions.
Is the Intas product the same as Sondelbay in Europe?
Sondelbay is held in Europe by Accord, Intas's European arm, and Intas holds the Indian permission, so they are shown as one product.
Work with EvySaif on teriparatide
Teriparatide 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 teriparatide, 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)S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory 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)
Planning teriparatide biosimilar development?
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