FDA’s Proposal for Naming Biosimilars Pleases Some, Disappoints Others
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of biosimilars has been an area of controversy because, unlike generic drugs, biosimilar biological products are only biosimilar to and cannot be the same as the originator product. Many have argued that distinct nonproprietary names (also known as proper names) for originator products and their biosimilars are necessary to protect patients. Biosimilar makers have argued that distinct names will impede the adoption of biosimilars.
After years of debate, FDA released a draft guidance that adopts a middle-road approach. Unlike small-molecule drugs, where the branded and generic drugs share the same nonproprietary name, FDA’s guidance provides distinct nonproprietary names for biological products. FDA proposes that all biological products carry the nonproprietary name of the originator biological product, along with a unique suffix to identify originator biological products, related biological products, and biosimilar products. But FDA’s proposed unique suffix is a random collection of four letters that is neither meaningful nor memorable. It is “devoid of meaning” to address concerns of biosimilar makers that distinctive names will discourage adoption of biosimilars.
The FDA’s guidance document has been long-awaited by the healthcare industry. Under the new guidance, healthcare providers will be able to differentiate among biological products to minimize inadvertent substitution of biological products that have not been determined by the FDA to be interchangeable. According to the FDA, the new naming convention is designed to “maximize the success of biosimilar products and interchangeable products and to help ensure the safety of patients receiving biological products licensed under the [Public Health Services] Act.”
In practice, the FDA intends to use a “core name” that is shared among all related biological products. For originator biological products, FDA will use the name adopted by the USAN Council for the drug substance as the core name. If the biological product is a related, biosimilar, or interchangeable product, the core name will be the nonproprietary name of the originator biological product, e.g., filgrastim in the case of Amgen’s Neupogen. A suffix of four lowercase letters will be added to the core name of each biological product, including the originator product, with a hyphen. The suffix must be a unique series of four letters and may not be promotional, such as making misrepresentations with respect to safety or efficacy. For example, Sandoz’s Zarxio, a biosimilar of Amgen’s Neupogen product, will have the nonproprietary name “filgrastim-bflm.” Zarxio had previously been given the placeholder name “filgrastim-sndz.”
According to the FDA, the suffix “will provide a consistent, readily available and recognizable mechanism for patients and health care professionals, including providers and pharmacists, to correctly identify these products.” FDA chose a suffix instead of a prefix so that products with the same core name will be grouped together in electronic databases.
The FDA explained that by requiring suffixes for all biological products, including originator products, it intends to promote pharmacovigilance while “avoid[ing] inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway.” That is, requiring both originator and biosimilar biological products to carry a four-letter suffix will avoid giving medical professionals and patients the impression that biosimilar products differ from the originator products in a clinically meaningful way. The FDA does, however, request feedback from the public as to whether the nonproprietary name for an interchangeable biological product should share the same suffix as the originator product. Comments should be submitted by October 27, 2015.
The FDA is also seeking comment on the best approach to implementing its naming convention for previously licensed products. It has issued a proposed rule to designate nonproprietary names with distinguishing suffixes for six previously licensed biological products. Each of the six products is either an originator biologic for an approved or publicly disclosed biosimilar application or a biological product that is related to one of the originator biologics. The proposed nonproprietary name for Amgen’s Neupogen, for example, is “filgrastim-jcwp.” Comments on the rule should be submitted by November 12, 2015.
Patient advocacy groups praised FDA’s guidance, saying that distinctive names are needed for patient safety. The American College of Rheumatology said that “[d]istinctive names will allow for greater transparency in substitution and notification, making it clear to all parties involved – pharmacists, providers and patients – which drug the patient is receiving.” The Global Healthy Living Foundation called FDA’s guidance “a major win for patients and physicians.” The Biologics Prescribers Collaborative (BPC) also commended FDA’s decision to require distinctive names. BPC said that the “prescribers who work every day with biologics – and their patients – are winners from FDA’s decision. The agency recognized that distinguishable names are essential to pharmacovigilance, patient safety, and transparency.”
The Alliance for Safe Biologic Medicines (ASBM), a group of biotech companies, was supportive of FDA’s decision to use distinctive names but thought the guidance did not go far enough. The ASBM called for a “meaningful, intuitive suffix applied consistently to all products by a single manufacturer” as opposed to FDA’s proposal for a suffix “devoid of meaning.” ASBM pointed to FDA’s placeholder name for Sandoz’ Zarxio as “filgrastim-sndz” as an example of a nonproprietary name with a meaningful suffix, explaining that the “sndz” suffix was “not only memorable and logical” but also promoted manufacturer accountability by associating the product with its manufacturer. FDA is soliciting public feedback on precisely this issue, i.e., “the benefits and challenges of [using] … a suffix derived from the name of the license holder.”
By contrast, the Biosimilars Council, a division of the Generic Pharmaceutical Association was disappointed with any distinctive names. It argued that FDA’s “naming conventions warrant serious scrutiny for their potential to erect barriers to patient access to new, more affordable medicines, and jeopardizes their safety.” The Biosimilars Counsel said that “[a]dding a random collection of letters to the product’s nonproprietary name confers no additional safety benefit, and in fact would require the healthcare professional to be armed at all times with a code-breaking reference.” The Academy of Managed Care Pharmacy (AMCP) also voiced its disappointment with FDA’s decision to use distinctive nonproprietary names. AMCP expressed “concern 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.”
The FDA’s draft guidance and proposed rule will undoubtedly receive significant public comment before they are finalized. In the meanwhile, patients and healthcare providers are satisfied with FDA’s middle-road approach.