ALL ABOUT BIOSIMILARS
We are dedicating this issue to biosimilars because we have received a lot of inquiries regarding the FDA Guidance for Industry, Nonproprietary Naming of Biological Products (January 2017) and the development of the 4-letter suffix.
According to FDA’s Guidance, a proper name includes the core name or active ingredient and a 4-letter suffix devoid of meaning. We are still seeing some inconsistencies on names approved based on the timing of the application but that should be revised over time. Recently, some biologics were approved with a 4-letter suffix (i.e. vestronidase alfa-vjbk (Mepsevii®), emicizumab-kxwh (Hemlibra®) and voretigene neparvovec-rzyl (Luxturna™)) while benralizumab (Fasenra®) was approved without a 4-letter suffix.
4-LETTER SUFFIX FAQ’S
Q: What type of biologic applications are within the scope of the FDA’s 2017 non-proprietary naming guidance?
A: The 2017 guidance applies to originator biological products, related biological products, and biosimilar products previously licensed and newly licensed under section 351(a) or 351(k) of the PHS Act which includes biological products regulated by both the Center for Drug Evaluation and Research (CDER) and the Center for Biologic Evaluation and Research (CBER).
Q: How many suffixes can you submit?
A: An applicant may submit up to 10 proposed suffixes for review, or the FDA may generate one for the applicant as part of the proprietary name approval process.
Q: Does the Agency reject 4-letter suffixes like they reject brand names?
A: Yes. The 4-letter suffixes must conform to the biologics naming guidelines, and suffixes that are found to be “meaningful” during the review process will most likely be rejected.
In some respects, understanding why names are rejected actually helps bring more clarity to the review process. Some reasons cited by the Agency for rejection of a proposed suffix include:
- Directly representing the product including mechanism or site of action
- Directly representing the sponsor
- Connoting the non-proprietary name
- Using a medical abbreviation that is well known to the end users of the product or may present a risk for errors
Q: What if the suffixes provided by the sponsor are rejected?
A: After an initial rejection, the sponsor may propose additional suffixes for review or provide rationale for reconsideration. The Agency has also provided options for the sponsor to consider. However, if no alternative suffixes are accepted by the sponsor, the Agency will assign a randomly generated, pre-screened suffix to the non-proprietary name if the product is licensed within the review cycle.
SafeMark’s methodology, which follows FDA’s Guidelines, begins with an initial brand review to assess the core + 4-letter suffix. We also provide our clients with a risk assessment that reviews and prioritizes the potential suffixes.
SafeMark has recently added to their list of databases the FDA’s list of approved suffixes which is also incorporated into the FDA’s POCA system files.
If you have a question regarding your pharmaceutical brand or nonproprietary naming assignment – please send it to us at firstname.lastname@example.org
DID YOU HEAR? EMA IS RELOCATING TO AMSTERDAM!
In early March 2018, the European Medicines Agency (EMA) released a new tracking tool to follow the milestones and deliverables for the Agency’s exciting relocation to Amsterdam. The tracking tool will be updated every month. “EMA will move from London to Amsterdam before 29 March 2019, when the United Kingdom withdraws from the EU.” The Dutch authorities have committed to building completely new, tailor-made premises for EMA in the Zuidas business district which are expected to be available from 15 November 2019. For an interim period until the new building is complete, EMA will occupy temporary premises in the Sloterdijk area of Amsterdam.” Find out more at www.ema.europe.eu.
GUIDELINES IN PLACE, NOW FOR CONSISTENCY…
Here is a short summary of 4-letter prefix do’s and don’ts:
A proposed suffix SHOULD…
- Be unique
- Be devoid of meaning
- Be four lowercase LETTERS of which three are distinct
- Be nonproprietaryBe attached to the core name with a hyphen
- Be free of legal barriers that would restrict its usage
A 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
BIOSIMILARS AROUND THE WORLD
Separate from the INN scheme for naming biological substances and in particular similar to biological products (biosimilars), the World Health Organization (WHO) has not yet made recommendations regarding qualifiers. Health Canada and ISMP Canada recently conducted a survey regarding the naming of subsequent biosimilars for the Canadian market. If the unique, 4-letter suffix option is chosen, guidelines would be developed to align with the FDA’s biosimilar naming convention.
The European Medicines Agency (EMA) has decided to not use a suffix, and will rely on brand name, nonproprietary name, barcode, and lot number.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has a specific naming scheme for biosimilars that includes the INN, additional descriptors, and the unique suffix, BS.
The Australian Therapeutic Goods Administration (TGA) will use the Australian biological name without a specific biosimilar identifier suffix until a global recommendation is made.
With over two decades of experience, brandsymbol was founded with the goal of revitalizing the agency-client relationship by innovating and transforming the branding process, to deliver world-class solutions, customized for each client. Our proprietary i4 Methodology is engineered to provide senior-level expertise, global creative, advanced legal & regulatory solutions to deliver clients world-class brands that are based on facts and figures, not opinions and observations.
SafeMark is redefining the safety industry by implementing a new gold standard in name safety testing. Our primary objective is to provide healthcare clients with a simple and sequential approach to name safety testing that adheres to guidelines set forth by global governmental authorities.
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