Last reviewed 2026-04-19 · How we verify

Interferon-beta-1a, 44 microgram

EMD Serono · Phase 2 active Small molecule

Interferon-beta-1a, 44 microgram is a Small molecule drug developed by EMD Serono. It is currently in Phase 2 development. Also known as: Rebif®.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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-beta-1a, 44 microgram
Also known as	Rebif®
Sponsor	EMD Serono
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

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

Interferon-beta-1a, 44 microgram CI brief — competitive landscape report
Interferon-beta-1a, 44 microgram updates RSS · CI watch RSS
EMD Serono portfolio CI

Frequently asked questions about Interferon-beta-1a, 44 microgram

What is Interferon-beta-1a, 44 microgram?

Interferon-beta-1a, 44 microgram is a Small molecule drug developed by EMD Serono.

Who makes Interferon-beta-1a, 44 microgram?

Interferon-beta-1a, 44 microgram is developed by EMD Serono (see full EMD Serono pipeline at /company/emd-serono).

Is Interferon-beta-1a, 44 microgram also known as anything else?

Interferon-beta-1a, 44 microgram is also known as Rebif®.

What development phase is Interferon-beta-1a, 44 microgram in?

Interferon-beta-1a, 44 microgram is in Phase 2.

Manufacturer: EMD Serono — full pipeline
Also known as: Rebif®

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