Anakinra injection

Form: Injection(SQ)

Strength: 100 mg/mL

Reference Brands: Kinerso, Kineret(US)

Category: Immune Disorder

Anakinra prefilled pens, marketed as Kineret, are approved in both the US by the FDA and in the EU via EMA for rheumatoid arthritis, Still's disease, and autoinflammatory conditions. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety, manufacturing quality, and pharmacovigilance data. In the US, the FDA reviews detailed clinical trial and manufacturing information, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance is essential for timely approval, supporting safe and effective treatment options for autoimmune and autoinflammatory diseases worldwide.