Abatacept Pre-filled Syringe/ Autoinjector Generics - Manufacturers & Suppliers
Orencia(US & EU)
| Product/Composition:- | Abatacept Pre-filled Syringe/ Autoinjector |
|---|---|
| Strength:- | 125 mg/0.5 mL, 250 mg/1 mL |
| Form:- | Pre-filled Syringe or Autoinjector |
| Reference Brands:- | Orencia(US & EU) |
| MOQ | As per the manufacturer batch size |
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Abatacept inhibits T-cell activation by blocking CD80/CD86 co-stimulatory signals, reducing inflammation and immune response in rheumatoid arthritis. Benefits include rapid symptom relief, improved joint function, slowing disease progression, and convenient subcutaneous autoinjector or syringe administration, enhancing patient adherence and quality of life for autoimmune disease management.
Abatacept pre-filled syringes and autoinjectors are approved in the EU and US for rheumatoid arthritis and other autoimmune diseases. In the EU, brands like Orencia are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval is based on extensive clinical data, biosimilarity, and pharmacovigilance. Both regions require detailed dossiers for initial approval and ongoing safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support efficient market access for abatacept formulations, ensuring adherence to European and American standards for safe, effective biologic therapy, helping you navigate complex regulatory requirements seamlessly.