Global Coalition of Regulators Voices Confidence in Biosimilars

The International Coalition of Medicines Regulatory Authorities (ICMRA), an executive-level coalition of regulators from 29 medicines regulatory authorities from territories including Australia, Brazil, Canada, China, the European Union, and the United States, among others, recently released a statement of confidence in biosimilars.

In the statement aimed at educating healthcare professionals, ICMRA said that it aims to provide assurance for stakeholders on the robust regulatory process for approval and monitoring of biosimilars and to highlight the benefits that biosimilars can provide for both patients and healthcare systems at large.

Biosimilars are medicines with proven quality, manufactured to the same quality standards as other biologics, and are only approved after rigorous scientific evaluation.

They explain that biosimilars must demonstrate high similarity to their reference products and that the foundation for providing this evidence of similarity comprises the extensive comparability studies that are undertaken using state-of-the-art analytical techniques that allow for robust comparison of the products’ molecules. Full clinical programs are not necessary except to help address remaining questions that may require human data (such as pharmacokinetics) to evaluate.

ICMRA highlights the fact that biosimilars have been used safely for many years, and no relevant differences in adverse effects have been observed between biosimilars and their references.

While regulatory pathways differ across countries, and while substitution at the pharmacy level is an issue regulated by nations individually, global regulators have confidence in the rigor of the approval process for biosimilars, and many regulators—and providers—accept switching to biosimilars as part of clinical practice.

However, ICMRA notes, copy biologics—sometimes called biomimics or biocopies—that are not approved on the basis of a robust biosimilar regulatory pathway must not be considered biosimilars; these noncomparable products have not been assessed in extensive comparability studies, so their quality is not assured.