Biologics and biosimilars are standouts in the world of drug development. An FDA-approved biosimilar is highly similar to an already FDA-approved biological product, called the reference product, in terms of safety, purity and potency. More companies are pursuing the development of these large molecule drugs, and many are developing biosimilars to originator products. Due to the influx of biosimilar products seeking approval, the FDA released guidance in January 2017 on the nonproprietary naming of biologic products. It discusses the need for biological products to bear a nonproprietary name that includes an FDA-designated suffix. The name for each originator, related and biosimilar product will be a combination of the core name and a distinguishing suffix devoid of meaning and composed of four lowercase letters. For example, the medication Mvasi that was recently approved in September 2017 as a biosimilar for Avastin (bevacizumab) has the designation bevacizumab-awwb.
The FDA has deemed this system necessary for facilitating pharmacovigilance for these products. If safety issues arise after approval, identifying a biologic product’s manufacturer can help target remedial action. It will also aid healthcare practitioners and patients in identification of these products. Inadvertent substitution may lead to unintended alternating or switching between products that are not considered interchangeable. This naming system will eliminate the confusion associated with the prescribing and selection of specific biologic products.
The guidance also discusses prospective and retrospective naming. The new naming convention is warranted for both newly licensed and previously licensed products. For prospective naming, the applicant should propose a suffix at the time of licensure. The applicant should submit up to 10 proposed suffixes in order of preference. As for retrospective naming, a biologics license application (BLA) holder may propose a suffix for use in the name of currently licensed biologic products by submitting a prior-approval labeling supplement to its BLA. This applicant should also submit up to 10 proposed suffixes in order of preference. The FDA has also stated it will change the names of currently marketed biosimilars with nonproprietary names which do not fall into the new criteria, but that those modifications have not yet been implemented.
Finally, the guidance outlines the required criteria for the proposed suffixes.
The proposed suffix should:
- Be unique
- Be devoid of meaning
- Be four lowercase letters of which at least three are distinct
- Be nonproprietary
- Be attached to the core name with a hyphen
- Be free of legal barriers that would restrict its usage
The proposed suffix should not:
- Be false or misleading, such as by making misrepresentations with respect to safety or efficacy
- Include numerals and other symbols aside from the hyphen attaching the suffix to the core name
- Include abbreviations commonly used in clinical practice in a manner that may lead the suffix to be misinterpreted as another element on the prescription or order
- Contain or suggest any drug substance name or core name
- Look similar to or be capable of being mistaken for the name of a currently marketed product (e.g., should not increase the risk of confusion or medical errors with the product and/or other products in the clinical setting)
- Look similar to or otherwise connote the name of the license holder
- Be too similar to any other FDA-designated nonproprietary name suffix
The FDA will evaluate the proposed suffixes and will notify applicants if they are acceptable or unacceptable. If the applicant does not submit a suffix that the FDA finds acceptable, the applicant may submit additional suffixes or the FDA may assign a suffix. To date, the FDA’s Center for Drug Evaluation and Research has approved seven biosimilars: Amjevita (adalimumab-atta), Cyltezo (adalimumab-adbm), Erelzi (etanercept-szzs), Inflectra (infliximab-dyyb), Mvasi (bevacizumab-awwb), Renflexis (infliximab-abda), and Zarxio (filgrastim-sndz).
The FDA has recently published new guidance that informs healthcare providers about biosimilars and their approval process. Since biological products are the fastest-growing class of therapeutic products, continued education is imperative to ensure patient safety. Stay informed about emerging drug information, including biologics and biosimilars, by updating or registering your profile to receive email alerts and other critical drug information updates from PDR. You can also stay current by using the official PDR app, available now for free from your favorite app stores.