Our client was based in the EU and was seeking to develop a biosimilar to an existing product approved in the US. As a relatively new entrant to the biosimilars sector, the client was capable of manufacturing the product and demonstrating batch-to-batch consistency, but had limited experience and exposure to the US regulatory framework for the development of biosmilars.

Woodley BioReg was approached to help define the process and activities to enable product development in the US. Our team identified a number of clinical and CMC areas that would require input and regulatory agreement as part of de-risking the development of the client’s biosimilar.

We led the development of the Type C meeting Briefing Book, including refining the client’s questions and defining the Applicant’s position. We also led the meeting with FDA and ensured all follow-up actions and activities were completed and reported.

Following the Type C meeting, Woodley BioReg has continued to support the client through scientific advice meetings with EMA and MHRA, and is now in the process of completing the clinical studies and simultaneously preparing the marketing authorisation application.

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