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Biosimilar
Biosimilar is a Biologic drug developed by Opal Rheumatology Ltd.. It is currently in Phase 2 development. Also known as: Brenzys, All other anti-TNF biosimilars as they come to market, Inflectra, Erelzi.
A biosimilar is a biologic medical product that is an almost identical copy of an original product, manufactured by a different company. Biosimilars are officially approved versions of original products, which can be manufactured when the original product's patent expires, such as the biosimilar SHR-A1811, which targets the Receptor tyrosine-protein kinase erbB-2.
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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).
| 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 | Biosimilar |
|---|---|
| Also known as | Brenzys, All other anti-TNF biosimilars as they come to market, Inflectra, Erelzi |
| Sponsor | Opal Rheumatology Ltd. |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer (PHASE2)
- Nivolumab in Treating Patients With Localized Kidney Cancer Undergoing Nephrectomy (PHASE3)
- Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (PHASE3)
- Paclitaxel and Carboplatin With or Without Bevacizumab in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer (PHASE3)
- Brentuximab Vedotin and Nivolumab With or Without Ipilimumab in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma (PHASE1, PHASE2)
- Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer (PHASE1)
- Pembrolizumab Plus CA-4948 for the Treatment of Patients With Progressive Metastatic Urothelial Cancer Despite Prior Immunotherapy (PHASE1)
- Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma (PHASE2)
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:
- Biosimilar CI brief — competitive landscape report
- Biosimilar updates RSS · CI watch RSS
- Opal Rheumatology Ltd. portfolio CI
Frequently asked questions about Biosimilar
What is Biosimilar?
Who makes Biosimilar?
Is Biosimilar also known as anything else?
What development phase is Biosimilar in?
Related
- Manufacturer: Opal Rheumatology Ltd. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Brenzys, All other anti-TNF biosimilars as they come to market, Inflectra, Erelzi
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing