• Safety & Recalls
  • Regulatory Updates
  • Drug Coverage
  • COPD
  • Cardiovascular
  • Obstetrics-Gynecology & Women's Health
  • Ophthalmology
  • Clinical Pharmacology
  • Pediatrics
  • Urology
  • Pharmacy
  • Idiopathic Pulmonary Fibrosis
  • Diabetes and Endocrinology
  • Allergy, Immunology, and ENT
  • Musculoskeletal/Rheumatology
  • Respiratory
  • Psychiatry and Behavioral Health
  • Dermatology
  • Oncology

Biosmilars’ naming proposal could cause “significant” changes


Pharmacies should be wary of potential drug name changes that could occur if FDA finalizes its new draft guidance on biosimilar naming, which proposes proper names for biosimilars.

Pharmacies should be wary of potential drug name changes that could occur if FDA finalizes its new draft guidance on biosimilar naming, which proposes proper names for biosimilars.

Related: [BLOG]: 5 reasons biosimilars must have distinguishable names

FDA’s draft guidance proposes that reference products and biosimilars have nonproprietary names (also called proper names) that share a core drug substance name and, in order to better identify each product, an FDA-designated suffix that is unique for each product, Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research (CDER) and Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research, wrote in a FDAVoiceblog post.

With what is being proposed, products that would have been previously grouped automatically under current IT systems will now be separate. It is foreseeable that there will be a need for significant database/software changes to accommodate the new system. This is compounded by new names for old products. This has never occurred before,” said Gillian Woollett, senior vice president of advisory firm Avalere Health.

Related: 5 reasons to keep biosimilar names the same

The non-proprietary name is used to group/bundle like products for multiple purposes such as in formularies and in safety alerts, according to Woollett.

Consumer advocacy groups, meanwhile, support FDA’s proposal. “Unique, distinguishable names for all biological medications are needed to ensure accurate tracking of medication utilization and adverse events, reduce patient and physician confusion and to enable a transparent system,” according to a statement from Patients for Biologics Safety & Access (PBSA), a coalition of more than 20 patient advocacy organizations dedicated to protecting patient access to safe and effective biologics

This suffix would be composed of four lowercase letters, and not carry any meaning. For example, the nonproprietary name of a reference product could be replicamab-cznm, and a biosimilar to that product could be replicamab-hixf, according to Woodcock and Mithun.


FDA is also asking for public comments on interchangeable biological products. “Our proposal requests feedback from the public about whether the nonproprietary name for such a product should include a distinct suffix, or should share the same suffix as its reference product (eg, the nonproprietary name of both the reference product and the interchangeable product could be replicamab-cznm),” Woodcock and Midthun wrote.

PBSA will provide comments on biosimilars and proper names.”One area we are particularly interested in is the development of an adverse event reporting system that is functional and universal,” the organization stated.

The impact of the draft guidance will initially be greatest for currently established ‘originator products’ to which biosimilars are being made, according to Woollett.

Read next: Patient groups bothered over diminished safety standards for biosimilars

Related Videos
© 2024 MJH Life Sciences

All rights reserved.