Unique names key factor to ensure patient-safety in biosimilar pathway
WASHINGTON – The Food and Drug Law Institute (FDLI) Policy Forum today published a white paper on biosimilar naming authored by the Alliance for Safe Biologic Medicines (ASBM). “It’s All About the Name: What is the Imperative of Adopting Unique Names For Biologic and Biosimilar Therapeutics?” explains that in order to ensure patient-safety as biosimilars are approved in the U.S., they must be given distinct, non-proprietary names. The paper identifies key challenges and practical solutions to help facilitate a solution to ensure safety is the cornerstone of the biosimilars pathway.
In the paper, ASBM makes four policy recommendations:
- All biologics should receive distinct non-proprietary names.
- United States Pharmacopeia (USP) should work with FDA to adapt the product monograph system to accommodate the unique attributes of structurally-related, but distinct, biologic medicines.
- The non-proprietary name of a reference product and product/s biosimilar to it should have a common, shared root but have distinct and differentiating suffixes.
- Products designated interchangeable should have a distinct name from the reference product for which they are considered interchangeable to facilitate accurate attribution of adverse events.
“As an organization, ASBM has been working with our diverse membership and Advisory Board that represents patients, physicians, pharmacists, scientists, manufacturers and academics to support the FDA as they work to bring biosimilars to patients in the U.S.,” said Dr. Richard Dolinar, ASBM Chairman. “Naming has been a prominent biosimilar safety issue and we are honored to be featured in FDLI’s publication and hope that this paper helps identify the challenges and solutions we need to take into consideration.”
FDLI’s Food and Drug Policy Forum is a concise (approximately 10 page), twice-a-month, peer-reviewed, digital publication on current food and drug policy topics. Posed in the form of a question, each issue provides subscribers and purchasers with pertinent background information, relevant research, a discussion of central issues, relevant resources, and policy recommendations.
Read the paper here.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. Visit us at www.SafeBiologics.org.
About the Food and Drug Law Institute
The Food and Drug Law Institute, founded in 1949, is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. The scope of FDLI includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. As a not-for-profit 501(c)(3) organization, FDLI does not engage in advocacy activities. FDLI’s Mission is to provide education, training, and publications on topical food and drug law; act as a liaison to promote networking as a means to develop professional relationships and idea generation; and ensure an open, balanced marketplace of ideas to inform innovative public policy, law, and regulation.