The International Coalition of Medicines Regulatory Authorities, 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.
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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
The Subcutaneous Revolution: Zymfentra and the Future of IBD Care With Dr Andres Yarur
December 17th 2023On this episode of Not So Different, Andres Yarur, MD, a researcher and associate professor of medicine at Cedars-Sinai Medical Center, discusses the significance of the FDA approval for Zymfentra, the world's first subcutaneous infliximab product, for patients with inflammatory bowel disease (IBD).
BioRationality: MHRA's Procedure Enables Automatic Registration of Biosimilars Approved Elsewhere
March 18th 2024Sarfaraz K. Niazi, PhD, explains how the new international recognition procedure under the Medicines and Healthcare Products Regulatory Agency (MHRA) could expand biosimilar access within the United Kingdom, in his latest column.