Brand Institute's President Of Central European Market Analyzes Drug Brand Name Approvals For Biosimilars

Miami, FL /PRNewswire/ - A biosimilar medicine is developed to be highly similar to an existing biological, or reference, product. The biosimilar and its reference product can be compared to leaves on a tree: they appear the same and serve the same purpose, but there are small differences due to the complexity of their development.

An analysis of biosimilar approvals reveals three naming strategies employed:

• Reference product–associated, as with REMSIMA (biosimilar) and REMICADE (reference product). This strategy evokes the reference product's brand name without infringing trademarks or raising other name safety concerns.
• Referring to the international nomenclature name (INN), as with ACCOFIL from pegfilgrastim. This strategy leverages subtle associations with the nonproprietary name registered as an INN. Overt associations are discouraged by regulators.
• Independent names, as with MOVYMIA (teriparatide) sharing no associations with its reference product, FORSTEO. This strategy utilizes a new name with no associations with existing pharmaceutical nomenclature, providing a clean slate from which to build one's brand.

"These names varied in tonality and associations overall," said Steffen Lorenz, President of Brand Institute, Frankfurt. "The creative direction reflects strategic discussions with the project team, and there is no one-size-fits-all strategy. Performing market research is always recommended to determine which strategy best fits the product."

Most approved brand names are INN-related or independent. A much smaller percentage evoke the reference product's brand name.

About Brand Institute and our wholly owned regulatory subsidiary, Drug Safety Institute
Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 4,000 marketed healthcare brand names, 1,300 USAN/INN nonproprietary names for 1,200 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers. Drug Safety Institute is composed of former naming regulatory officials from global government health agencies, including Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada (HC), American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling.