International Coalition of Medicines Regulatory Authorities Declares Confidence in Biosimilars

September 20, 2019

Biosimilars Team

The International Coalition of Medicines Regulatory Authorities (ICMRA)—a voluntary, executive-level, strategic coordinating, advocacy and leadership entity of 29 regulatory authorities from every region in the world (with the World Health Organization as an observer)—has declared confidence in biosimilar products in separate statements for healthcare professionals and patients/the public.

According to ICMRA, the statements are intended “to give assurance that regulators have robust processes in place for the approval and monitoring of biosimilars and highlight the benefits biosimilars can provide for patients and healthcare systems in terms of increased treatment options, access and cost competition.”

The statement for healthcare professionals addresses the following key points:

  • Biosimilars are biological medicines of proven pharmaceutical quality.
  • Biosimilars are approved after rigorous scientific evaluation by regulatory authorities.
  • As part of the assessment process, biosimilars must demonstrate that they are highly similar to an already approved originator biological medicine.
  • A full clinical development program is not necessary when extensive laboratory testing has demonstrated that the biosimilar is highly similar to the originator.
  • Biosimilars have been used safely for many years.
  • Globally, regulators have confidence in the rigor of the scientific review and approval process for biosimilars.
  • Biosimilars enhance competition among biological medicines.
  • Biosimilars have been increasingly used in clinical practice in most countries.

The statement for patients and the public provides answers to questions such as:

  • What are biosimilars?
  • How do biosimilars compare to originator biological medicines?
  • Are biosimilars safe to use?
  • What are the advantages of biosimilars?

The statements are available for download on the ICMRA website.