Biosimlars: BIO Comments on EMA Guideline on Similar Biological Medicinal Products (CHMP/437/04 Rev1)

The Biotechnology Industry Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the revised “Guideline on Similar Biological Medicinal Products (CHMP/437/04 Rev1).” BIO commends EMA on the update of this Draft Guideline, which provides an important international precedent for the regulation of biosimilar biological medicinal products.

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.

BIO appreciates this opportunity to comment on the revised “Guideline on Similar Biological Medicinal Products (CHMP/437/04 Rev1).” We would be pleased to provide further input or clarification of our specific, detailed comments, which follow in Section 2, as needed.