Regulators Stand Up for Biosimilars

A recent statement from an international group of regulators could help.

To calm uncertainty, the International Coalition of Medicines Regulatory Authorities published a statement of confidence in biosimilars.  The coalition’s statement outlines what biosimilars are, data requirements for approval and the reasoning for the requirements.  The statement notes the history of success of biosimilars approved under current regulations.

The International Coalition of Medicines Regulatory Authority includes 29 regulatory authorities from across the world, including the U.S. Food and Drug Administration and the European Medicines Agency.  Overseen by the World Health Organization, the coalition addresses safety and regulatory challenges and offers regulatory direction to its members.

As a global authoritative entity, the International Coalition of Medicines Regulatory Authority can have a far-reaching impact with its statement of support. Two versions of the statement were published. The first targets patients and the public, who may be unfamiliar with what biosimilars are. The second targets health care providers, who know that biosimilars are highly similar but not identical to an approved biologic medicine. These providers also recognize that approval of a biosimilar typically does not require evidence from traditional, full-length, clinical trials.  An international statement could assuage any concerns about these differences and increases awareness among providers of biosimilars as a quality therapeutic option.

Greater physician confidence could, in turn, encourage widespread adoption of biosimilars and improve access to innovative treatments for patients around the world.