Interferon alfa-2b biosimilars
An antiviral protein once central to hepatitis treatment, with Indian biosimilars since 2009 and none in the United States, Europe, Japan or Canada.
About interferon alfa-2b
Interferon alfa is a copy of a natural protein the body makes to fight viruses. A longer-acting pegylated form, given once a week, was for years the standard treatment for hepatitis C and B alongside ribavirin.
It switches on the cell's own antiviral defences and boosts immune cells that attack infected cells and some cancer cells.
An injection under the skin, three times a week for the plain form and once a week for the pegylated form, from vials or pens.
Chronic hepatitis B and C, and several blood cancers, melanoma and Kaposi's sarcoma.
A biosimilar would be compared in the laboratory, in volunteers using blood markers of interferon activity, and in a clinical study in hepatitis. That study has become hard to run since newer antiviral tablets replaced interferon in hepatitis C.
The reference products are Intron A and PegIntron, from Merck. Both European approvals have since been withdrawn as the hepatitis C market moved to newer drugs.
Interferon alfa is a biosimilar market that arrived and left before the West engaged. India, China and Iran built products for hepatitis in the 2000s, Europe refused the one application it received, and newer antivirals then removed the largest use. The Indian permissions stand, and the pegylated product found a second life during the pandemic.
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
- Todaythree interferon alfa-2b 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| EMA | Alpheon | BioPartners GmbH | not published | EMEA/H/C/000585 | Withdrawn | S017 | |
| CDSCO | USV (INN only) | USV Ltd | Sep 2009 | Import permission | Approved | S013 | |
| CDSCO | Cadila Healthcare (INN only) | Cadila Healthcare Ltd | Jun 2011 | MF-266/11 | Approved | S014 | |
| CDSCO | Intas Biopharmaceuticals (INN only) | Intas Biopharmaceuticals Ltd | Apr 2013 | MF-89/2013 | Approved | S014 |
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 an interferon alfa-2b 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) is available; no interferon biosimilar has been filed in the United States | 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 interferon alfa-2b programmes. Regulatory strategy consulting
Presentations and concentration
Peginterferon alfa-2b: 50, 80, 100, 120 and 150 microgram lyophilised vials or pens. Interferon alfa-2b: 3, 5 and 10 million IU vials.
| Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| USV interferon alfa-2b | · | · | · | · | · | 3 and 5 million IU lyophilised vials | · |
| Zydus peginterferon alfa-2b | · | · | · | · | · | Lyophilised peginterferon alfa-2b for subcutaneous injection | · |
| Intas peginterferon alfa-2b | · | · | · | · | · | Pegylated interferon alfa-2b in vials and syringes | · |
| Alpheon | · | see SmPC | · | · | · | · | · |
EU presentations are listed in each product's SmPC.
Developers by market
| Developer | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|---|
| Not stated in the CDSCO list | USV interferon alfa-2b | · | · | · | · | · | ✓ | · |
| Cadila Healthcare (Zydus Lifesciences) | Zydus peginterferon alfa-2b | · | · | · | · | · | ✓ | · |
| Intas Pharmaceuticals | Intas peginterferon alfa-2b | · | · | · | · | · | ✓ | · |
| BioPartners | Alpheon | · | withdrawn | · | · | · | · | · |
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
USV interferon alfa-2b
Zydus peginterferon alfa-2b
Intas peginterferon alfa-2b
Alpheon
In development
No comparative trial of an interferon alfa-2b 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
Is there an interferon alfa biosimilar in the United States or Europe?
No. Europe refused the one application, in 2006, and none has been filed in the United States.
Is there an interferon alfa-2b biosimilar in India?
Yes. USV imports a product, and Zydus and Intas hold permissions for the pegylated form, Zydus's being the first pegylated interferon biosimilar anywhere.
Which interferon biosimilars are registered in the UAE?
None. Roche's Pegasys is registered.
Why did the interferon biosimilar market not develop in the West?
Newer antiviral tablets replaced interferon in hepatitis C, the largest use disappeared, and the originators withdrew their European approvals.
What was the COVID-19 use in India?
Zydus's pegylated interferon received a restricted emergency indication for moderate COVID-19 in 2021.
How would an interferon biosimilar be tested?
Laboratory comparison, a volunteer study using blood markers of interferon activity, and a clinical comparison in hepatitis B.
Work with EvySaif on interferon alfa-2b
Interferon alfa-2b 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 interferon alfa-2b, with the gaps ranked and a filing sequence recommended.
About the gap assessmentSources
S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S018UAE Emirates Drug Establishment, registered medical product directory Primary (regulator)S009CDSCO and DBT, Guidelines on Similar Biologics 2016 Primary (regulator)S010CDSCO, Draft Guidelines on Similar Biologics 2025 Primary (regulator)
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