Last reviewed 2026-05-31 · How we verify

EU-Sourced Orencia®

Momenta Pharmaceuticals, Inc. · Phase 1 active Biologic ✓ Verified May 2026

EU-Sourced Orencia® is a Biologic drug developed by Momenta Pharmaceuticals, Inc.. It is currently in Phase 1 development. Also known as: Abatacept.

EU-Sourced Orencia and US-Sourced Orencia were compared in a study to assess their pharmacokinetics and safety in healthy volunteers. The study, NCT02923583, was a randomized, double-blind, three-arm, parallel group, single-dose study conducted by Momenta Pharmaceuticals, Inc.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	EU-Sourced Orencia®
Also known as	Abatacept
Sponsor	Momenta Pharmaceuticals, Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Assessment of Pharmacokinetics (PK) and Safety of M834 and Orencia ®, in Healthy Subjects (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

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

EU-Sourced Orencia® CI brief — competitive landscape report
EU-Sourced Orencia® updates RSS · CI watch RSS
Momenta Pharmaceuticals, Inc. portfolio CI

Frequently asked questions about EU-Sourced Orencia®

What is EU-Sourced Orencia®?

EU-Sourced Orencia® is a Biologic drug developed by Momenta Pharmaceuticals, Inc..

Who makes EU-Sourced Orencia®?

EU-Sourced Orencia® is developed by Momenta Pharmaceuticals, Inc. (see full Momenta Pharmaceuticals, Inc. pipeline at /company/momenta-pharmaceuticals-inc).

Is EU-Sourced Orencia® also known as anything else?

EU-Sourced Orencia® is also known as Abatacept.

What development phase is EU-Sourced Orencia® in?

EU-Sourced Orencia® is in Phase 1.

Manufacturer: Momenta Pharmaceuticals, Inc. — full pipeline
Also known as: Abatacept

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