By Betsy Lard, Vice President, Managing Director of Addison Whitney, part of INC Research/inVentiv Health
Small changes in regulatory guidance can translate to big risks if you’re not adjusting your strategy and timelines proactively. A delay as short as six months in a pharmaceutical product launch can result in an average loss of $100 million.[1]
Naming your asset – or more specifically, navigating the regulatory obstacles and variables of gaining name approval – is critical to maintaining an on-time launch strategy.
Know the Current Regulatory Climate – Globally
This year brought changes from three major regulatory bodies that may impact your drug name submission.
FDA Issues Guidance on Biological Products
In 2017 the FDA published guidance, finalizing an August 2015 draft, on the nonproprietary naming of biological products. This requires that biological product names should include a core name plus a four-letter suffix. Applying suffixes is intended to accurately track drugs to a specific manufacturer, to improve record keeping and pharmacovigilance, and to minimize medication errors when a biosimilar is not licensed as interchangeable.
This guidance applies to already licensed and newly licensed originator biological products, related biologic products and biosimilar products. Suffixes should be unique and devoid of meaning, made up of four lowercase letters (three of which are distinct) and be non-proprietary and free of legal barriers that would restrict their use. The suffixes should not be suggestive of drug substance or core name, or be abbreviations commonly used in clinical practice.
Expert Tip: To ensure adequate time to address legal considerations and vet biosimilar naming strategies with executives, it’s important to be thoughtful about when you submit a biosimilar product name to the FDA. Two or three years ahead of your filing, or toward the end of Phase II may be ideal for submitting a name for consideration, so planning must begin with building in adequate time for creation, screening and internal buy-in for suffixes.
EMA Changes its Review Schedule
Recent changes in the EMA name review schedule are influencing launch planning in Europe. This year, the EMA Name Review Group (NRG) reduced the number of its review meetings (along with the corresponding submission deadlines) from six to four annually, or one per quarter. The EMA NRG also instituted a new cap of approximately 100 reviews per session. Timing is key – names that are not accepted for review in a given EMA quarterly meeting will be postponed to the next quarterly meeting.
Expert Tip: With the reduced number of NRG meetings, the timing implications of missing a deadline or having to resubmit following a rejection are more impactful. Teams should increase their chance for approval during the first EMA submission by conducting name assessment research to choose viable names and by submitting two name candidates.
The EMA NRG will review two names, in parallel and independent of each other. (In contrast, the FDA reviews one name at a time.) In 2016 only 36 percent of companies that submitted one name for review to the EMA NRG were granted approval, as opposed to 67 percent of those that submitted two names.[2]
If a global name is preferred and the overall launch strategy and timing allow, many teams choose to submit to the EMA first to get feedback on two name candidates, and then submit one EMA-approved name to the FDA.
Health Canada’s Naming Guidance – Lessons Learned Two Years Out
In the summer of 2015, Health Canada released official guidance for their name submission process, which made it mandatory for sponsors to conduct and submit results of a brand name assessment. These regulations helped to provide more clarity for the agency’s review process, but like most new laws, the full effect isn’t really understood until it’s been in practice.
During the first two years under the new guidance, our team supported more than a dozen Health Canada submissions, which resulted in approved names, but not much communication with the agency. In 2017, Health Canada reviewers were more active, with comments and questions on the Requests for Proprietary Name Review. That feedback led to several new best practices: 1.) More detailed rationale should be provided about why names were included or excluded from the Synthesize Phase; and 2.) The Synthesize Phase should take place within approximately six months of the New Drug Submission (and the Search Phase should be updated to ensure all similar drug names are taken into consideration).
Expert Tip: The new guidance requires specific analysis steps, including “Search,” “Simulate” and “Synthesize.” This detailed reporting requires additional analysis, so sponsors need to plan ahead for the extra time it can take to conduct and report on the multi-step assessment.
Planning for Success
These regulatory issues are just some of the considerations that need to be taken when it comes to brand asset naming. To ensure a successful submission strategy it is essential to:
- Start Early: Ensure you are leaving enough time for creating a strategy and getting legal, regulatory and commercial teams collaborating from the beginning to assess risks and potential strategies for addressing those risks. Time is also needed to screen candidate names.
- Find an Expert Partner: When it comes to naming your asset, find a partner – a company with both brand naming and regulatory experience – to guide you through these milestones and to develop the best regulatory submission strategy for your product.
Learn more about drug naming developments by watching a webinar featuring brand naming and regulatory specialists here.
