With 1 biosimilar already approved in the US, the FDA has finally released draft guidelines for naming these new products.
After the FDA approved the first biosimilar in the US, the discussion quickly turned to the next challenge: what would be the naming procedure for these new products?
Now, the FDA has released draft guidance detailing the proposed naming of biological products. The agency has proposed that reference products and biosimilars have names that share a core drug substance and an FDA-designated suffix to better identify each product.
“There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable,” the agency wrote in draft guidance for nonproprietary naming of biological products.
Another potential naming convention that the FDA is considering is the use of a suffix derived from the name of the license holder.
The FDA is including 6 previously licensed biological products, so filgrastim-sndz would become filgrastim-bflm, filgrastim would be filgrastim-jcwp, tbo-filgrastim would be filgrastim-vkzt, pegfilgrastim would be pegfilgrastim-ljfd, epoetin alfa would be epoetin alfa-cgkn, and infliximab would be infliximab-hjmt.
The naming convention for these 6 products is being considered because the FDA believes it would help prevent inadvertent substitution and will help protect the safety of patients.
The Academy of Managed Care Pharmacy (AMCP) quickly made known its displeasure with the proposal to name biologics, including reference products and biosimilars, with a nonproprietary name with an FDA-designated suffix.
AMCP Chief Executive Officer Edith A. Rosato, RPh, IOM, said in a statement that since the current naming convention has been proven safe for biological products in Europe, it should be used in the US as well.
“AMCP is concerned that any departure from the currently accepted nonproprietary naming system will create confusion amongst healthcare practitioners and patients, have negative effects on the ability to ensure safe dispensing and tracking, and result in lower market adoption and cost-savings,” she said.
Read more on Biosimilars
As Date for First Biosimilar to Hit the Market Draws Close, Reimbursement Remains Fuzzy
Biosimilar Essentials
Navigating Health Policy in an Election Year: Insights From Dr Dennis Scanlon
April 2nd 2024On this episode of Managed Care Cast, we're talking with Dennis Scanlon, PhD, the editor in chief of The American Journal of Accountable Care®, about prior authorization, price transparency, the impact of health policy on the upcoming election, and more.
Listen
Downward Morbidity, Mortality Trends Discovered Among Patients With Ovarian Cancer, Liver Metastases
April 24th 2024This study indicates a declining trend in morbidity and mortality rates among patients with ovarian cancer and liver metastases, highlighting the efficacy of surgery and chemotherapy in improving survival outcomes.
Read More
Polatuzumab Vedotin and R-CHP Appropriate for Untreated DLBCL
April 24th 2024Population pharmacokinetic and exposure-response analyses revealed a favorable benefit-risk profilane for the treatment combination of polatuzumab vedotin and rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP).
Read More