Biosimilar products registration, MAA, LCM, Type IA/IAIN/IB/II Variations

Freyr supports in MAA Submissions, registration & life cycle management (LCM) of biosimilar/biological medicinal products and helps in Compiling, reviewing and submission of Variations such as Type IA/Type IAIN/Type IB/Type II in EU countries.

Anticipated patent expiry for the blockbuster biological medicinal products attracted most of the Biopharmaceutical companies to develop Biosimilars for global markets including European Union (EU) countries. While registering marketing authorization applications (MAA – Article 10(4) Applications) for those Biosimilars, companies must ensure that the applications are in line with legal requirements and procedures laid down in Directive 2001/83/EC and in Regulation (EC) No. 726/2004. MAAs of Biosimilars must be submitted through Centralized Procedure (CP) and are subjected to the European Medicines Agency’s (EMA’s) evaluation.

Even though Biosimilars Regulatory submission pathway facilitates certain advantages for product development and Regulatory approvals (no requirement of conducting full-fledged non-clinical and clinical studies that may involve additional time and money), product development goals still have strict limitations.

To evaluate Article 10(4) Applications (MAAs of Biosimilars), a robust comparability exercise involving head-to-head comparison between the similar biological medicinal product and the Reference Medicinal Product (RMP) is required considering the levels of quality, safety and efficacy. In addition, manufacturers are required to go through different expression systems or different excipients for developing biosimilars, which adds to the burden of establishing similarity. Other challenges like optimal planning of clinical trial strategy to cover multiple member states/ countries, and selection of reference member state to fulfil global registration requirements are also prevalent.

Know more at Freyr Page - Biosimilar products registration, MAA, LCM, Type IA/IAIN/IB/II Variations

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