April 8, 2015
The Name Game: Controversy Continues on
Biosimilar Naming Policy
Washington, D.C.—What’s in a name?
Apparently a lot when it comes to biosimilars.
Recently, five advocacy groups—the American Autoimmune Related Diseases Association, Biologics Prescribers Collaborative, the Hematology/Oncology Pharmacy Association, National Alliance for Hispanic Health, and the National Organization for Rare Diseases—sent a letter to Office of Management and Budget Director Shaun Donovan emphasizing the need for unique naming of biosimilars.
The groups, which previously had sent similar letters to the FDA, asked Donovan to work with the FDA to issue a unique naming policy for biosimilars. The letters said the final policy is “…urgent, given that the FDA has now approved the first biosimilar in the United States.”
Last June, however, the American Pharmacists Association, the National Association of Chain Drug Stores, and the National Community Pharmacists Association sent a joint letter to the World Health Organization in support of assigning the same individual nonproprietary name to a biosimilar product that is assigned to the reference biologic counterpart.
“The approach is consistent with the naming convention for brand and generic small molecule drugs, and is familiar to healthcare providers and patients alike,” the pharmacy groups wrote. “Applying unique INNs to biosimilars deviates from traditional naming practices and could lead to general confusion related to the appropriate use, safety, and efficacy of biologic products, as well as therapeutic duplication that would be detrimental to patients’ health.”
In March, the FDA approved Zarxio (filgrastim-sndz), a Sanoz, Inc. product biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991.
Zarxio is approved for the same indications as Neupogen, and can be prescribed by a healthcare professional for:
• patients with cancer receiving myelosuppressive chemotherapy
• patients with acute myeloid leukemia receiving induction or consolidation chemotherapy
• patients with cancer undergoing bone marrow transplantation
• patients undergoing autologous peripheral blood progenitor cell collection and therapy
• patients with severe chronic neutropenia.
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product, according to the FDA. The agency further explained in a press release that the biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product, and only minor differences in clinically inactive components are allowable.
“Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, MD. “Patients and the healthcare community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”
The letter from the healthcare groups commended the FDA “for its careful deliberation on the naming issue and particularly for its carefully-crafted decision to give Zarxio (filgrastim-sndz) a temporary distinguishable name while the policymaking process continues.”
Proponents of unique names argue that the practice is more transparent considering that no two biologic drugs can ever be identical.
“We welcome the availability of biosimilars in the U.S. and believe the success of this class of medicines hinges on prescriber, patient, and pharmacist confidence,” according to the letter sent to Donovan. “Every patient who depends on biologic drugs deserves to know the exact drug they are using in order to make the best medical decisions in terms of both efficacy and safety. Given that no two biologics drugs can ever be the same, unique naming provides transparency that supports confidence in, and ultimately utilization of, these new medicines as well as critical post-market surveillance and tracking.”
|U.S. Pharmacist Social Connect