BIO Statement on European Pharmaceutical Legislation Requiring Testing for 'Biosimilar' Products

WASHINGTON, D.C. (December 18, 2003) — Biotechnology Industry Organization (BIO) President Carl B. Feldbaum issued the following statement in response to a vote by the European Union (EU) Parliament to approve pharmaceutical legislation that calls for appropriate tests for "biosimilars" — biological therapies that are similar to existing, approved biological therapies.

"The European Union Parliament has enacted sweeping legislation to establish uniformity in the pharmaceutical practices among the EU nations. Part of that legislation includes an important recognition of the need for appropriate regulatory requirements for so-called biosimilars to ensure their safety and effectiveness in patients.

"The EU recognizes that biosimilars are different from existing biological therapies in terms of their raw materials and manufacturing processes and that even slight differences can significantly alter a biological therapy's safety and effectiveness.

"Therefore, the EU will require companies that produce biosimilars to conduct appropriate tests.

"BIO supports the EU in its decision to require extensive tests for biosimilar medicines. Biological therapies are vastly different and more complex than conventional chemical drugs. As the EU correctly concluded, even slight changes in the therapies themselves or the processes used to create them can create significant differences in their safety and effectiveness.

"Without adequate clinical tests, patients cannot be assured that their biological therapies are safe and effective."

BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50 U.S. states and 33 countries. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products.