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US-Sourced Orencia®
US-Sourced Orencia® is a Biologic drug developed by Momenta Pharmaceuticals, Inc.. It is currently in Phase 1 development. Also known as: Abatacept.
US-Sourced Orencia is a medication that inhibits Interleukin-6, a protein involved in inflammation. It is classified as an inhibitor and has been studied in a clinical trial to assess its pharmacokinetics and safety in healthy subjects.
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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).
| 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 | US-Sourced Orencia® |
|---|---|
| Also known as | Abatacept |
| Sponsor | Momenta Pharmaceuticals, Inc. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
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:
- US-Sourced Orencia® CI brief — competitive landscape report
- US-Sourced Orencia® updates RSS · CI watch RSS
- Momenta Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about US-Sourced Orencia®
What is US-Sourced Orencia®?
Who makes US-Sourced Orencia®?
Is US-Sourced Orencia® also known as anything else?
What development phase is US-Sourced Orencia® in?
Related
- Manufacturer: Momenta Pharmaceuticals, Inc. — full pipeline
- Also known as: Abatacept
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing