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A critical question that is still eliciting much debate internationally is the naming convention for biosimilars; in other words, what should be their nonproprietary (noncommercial) name?

SMD generic medicines have the same nonproprietary names as their innovator medicines as the active ingredients in generics are identical to that in the innovator drugs. In contrast, biosimilars are not identical to innovator biologics. Giving all biologics, including biosimilars, different (distinguishable) nonproprietary names are consistent with the concept that no two versions of a biologic including a biosimilar are identical.⁵⁹

Views on the naming of biosimilars fall broadly in two groups. The first is that since a biosimilar is highly similar to its innovator biologic, it should have the same name as the innovator. The other view is that for safety reasons, it is critical to have a unique name for each biologic, including a biosimilar so each biologic can be identified individually.⁵⁹

Under the FDA's naming system, each biologic, innovator/reference product, and biosimilar receives a unique nonproprietary name; a “core” name followed by a unique (but meaningless) four‐letter suffix. Thus, each biologic has a unique, distinguishable name in the United States.

Europe, Australia, and Canada have adopted a different naming approach that incorporates distinguishable suffixes. These countries allow biologics including biosimilars to share nonproprietary names but have strengthened adverse event monitoring by either mandating inclusion of brand names or nonproprietary names as well as brand names in adverse event or pharmacovigilance reporting. In Australia, for example, the product's trade name, as well as the nonproprietary name, is a mandatory field when reporting an adverse event.⁶⁰

The naming of biosimilars has implications far beyond the marketing and commercial sphere; it may directly affect patients’ confidence in switching to biosimilars and traceability of each biosimilar product with respect to its efficacy and safety monitoring once on the market.