Insulin‑Aspart‑Szjj

Form: SQ Injection

Strength: 100 units/mL

Reference Brands: NovoLog; Merilog is biosimilar to NovoLog.

Category: Biosimilars

Merilog is regulated as a biosimilar to NovoLog (insulin aspart) in both the EU and US. In the US, FDA approval involves extensive comparability, safety, and efficacy data in accordance with GMP standards. In the EU, CE marking certifies conformity with MDR standards for biosimilarity, validated through dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality. These biosimilars undergo validation, stability testing, and audits, supported by comprehensive documentation including clinical data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to affordable, high-quality insulin biosimilars supporting optimal diabetes management worldwide.