Last reviewed 2026-05-31 · How we verify

Interferon alfa 2a [Roferon]

Hoffmann-La Roche · Phase 3 active Small molecule

Interferon alfa 2a [Roferon] is a Interferon alpha Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Chronic myeloid leukemia (CML), Hairy cell leukemia, Chronic hepatitis B.

Interferon alfa-2a activates the immune system by binding to interferon-alpha receptors on cell surfaces, enhancing natural killer cell and macrophage activity to fight viral infections and cancer cells.

Likelihood of approval

64.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
Big-pharma sponsor +3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Interferon alfa 2a [Roferon]
Sponsor	Hoffmann-La Roche
Drug class	Interferon alpha
Target	Interferon-alpha receptor (IFNAR1/IFNAR2)
Modality	Small molecule
Therapeutic area	Oncology, Immunology, Virology
Phase	Phase 3

Mechanism of action

Interferon alfa-2a is a cytokine that binds to type I interferon receptors (IFNAR1/IFNAR2) on immune and tumor cells, triggering intracellular signaling cascades that upregulate antiviral and anti-proliferative genes. This leads to increased expression of MHC molecules, enhanced cytotoxic T-cell and natural killer cell activity, and direct anti-proliferative effects on malignant cells. The drug also has immunomodulatory effects that enhance the host's innate and adaptive immune responses.

Approved indications

Chronic myeloid leukemia (CML)
Hairy cell leukemia
Chronic hepatitis B
Chronic hepatitis C
Melanoma (adjuvant therapy)
Kaposi sarcoma

Common side effects

Flu-like symptoms (fever, chills, fatigue)
Headache
Myalgia
Anorexia
Nausea
Leukopenia
Thrombocytopenia
Depression/mood changes
Thyroid dysfunction

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Interferon alfa 2a [Roferon] CI brief — competitive landscape report
Interferon alfa 2a [Roferon] updates RSS · CI watch RSS
Hoffmann-La Roche portfolio CI

Frequently asked questions about Interferon alfa 2a [Roferon]

What is Interferon alfa 2a [Roferon]?

Interferon alfa 2a [Roferon] is a Interferon alpha drug developed by Hoffmann-La Roche, indicated for Chronic myeloid leukemia (CML), Hairy cell leukemia, Chronic hepatitis B.

How does Interferon alfa 2a [Roferon] work?

What is Interferon alfa 2a [Roferon] used for?

Interferon alfa 2a [Roferon] is indicated for Chronic myeloid leukemia (CML), Hairy cell leukemia, Chronic hepatitis B, Chronic hepatitis C, Melanoma (adjuvant therapy).

Who makes Interferon alfa 2a [Roferon]?

Interferon alfa 2a [Roferon] is developed by Hoffmann-La Roche (see full Hoffmann-La Roche pipeline at /company/roche).

What drug class is Interferon alfa 2a [Roferon] in?

Interferon alfa 2a [Roferon] belongs to the Interferon alpha class. See all Interferon alpha drugs at /class/interferon-alpha.

What development phase is Interferon alfa 2a [Roferon] in?

Interferon alfa 2a [Roferon] is in Phase 3.

What are the side effects of Interferon alfa 2a [Roferon]?

Common side effects of Interferon alfa 2a [Roferon] include Flu-like symptoms (fever, chills, fatigue), Headache, Myalgia, Anorexia, Nausea, Leukopenia.

What does Interferon alfa 2a [Roferon] target?

Interferon alfa 2a [Roferon] targets Interferon-alpha receptor (IFNAR1/IFNAR2) and is a Interferon alpha.

Drug class: All Interferon alpha drugs
Target: All drugs targeting Interferon-alpha receptor (IFNAR1/IFNAR2)
Manufacturer: Hoffmann-La Roche — full pipeline
Therapeutic area: All drugs in Oncology, Immunology, Virology
Indication: Drugs for Chronic myeloid leukemia (CML)
Indication: Drugs for Hairy cell leukemia
Indication: Drugs for Chronic hepatitis B

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing