The study is to evaluate the regulatory requirements and prepare a bibliographic application dossier of biosimilar drug in the European Union. Biosimilars have been developed for several biologic therapeutic agents, including erythropoiesis-stimulating agents. The pathway adopted by the manufacturer of a biosimilar (epoetin zeta) to gain licensing within the European market will be assessed, analyzing its compliance with the European Medicines Agency guidelines for the approval process.

In Europe, the drugs are marketed only after the marketing authorization approval. European biosimilar medicines are approved through 4 marketing authorisation procedures namely, Centralised, Mutual recognition, National and Decentralized Procedures. In case of Well-established use application, According to Article 10a of Directive 2001/83/EC, as amended it is possible to replace results of preclinical and clinical trials by detailed references to published scientific literature. Applicants should submit Modules 1, 2 and 3 as described in EU- CTD, For Modules 4 and 5, a detailed scientific bibliography shall address all required pre- clinical and clinical characteristics, and should be summarized in Module 2.

Sonia is an Associate Professor in the Department of Pharmaceutical Chemistry at the Sri Ramachandra Faculty of Pharmacy, India.