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From Health Law Daily, August 28, 2015

FDA hopes to distinguish biosimilars, proposes official names for six products

By Kayla R. Bryant, J.D.

The FDA is proposing to designate official names for six biological products, mainly filgrastim products. Although the agency is still considering implementing a naming convention for all biologics, it has found a need to propose action for these particular products to encourage routine usage of designated suffixes. The FDA hopes that the establishment of these names will avoid inaccurate perceptions of the safety and effectiveness of these biologics (Proposed rule, 80 FR 52224, August 28, 2015).

New biologics. The FDA has noted that a number of new biological products will be entering the market following the abbreviated licensure pathway for biosimilars under the Biologics Price Competition and Innovation Act (BPCI Act), which was passed as part of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) under section 7002. Biosimilars are biologics that are highly similar to a reference product, with only some minor changes in inactive components. Biosimilars have no clinically meaningful differences from the reference product. The agency has received industry petitions about the nonproprietary naming of biosimilars, such as requesting that the FDA require products to bear names that are similar to or the same as their reference products. The agency released draft guidance for comment purposes on nonproprietary naming of biological products earlier this month.

The rule. Under this proposed rule, the FDA would designate the official and proper names of six particular biologics, identified by their biologics license application (BLA) numbers, as follows:

  • filgrastim-bflm (BLA 125553);

  • filgrastim-jcwp (BLA 103353);

  • filgrastim-vkzt (BLA 125294);

  • pegfilgrastim-ljfd (BLA 125031);

  • epoetin alfa-cgkn (BLA 103234); and

  • infliximab-hjmt (BLA 103772).

The agency believes that the naming conventions will help prevent inadvertent substitution of one product for another. This will facilitate the safe use of biologics, as switching biological products that are not interchangeable can affect an immune response. The agency is also concerned about pharmacoviligance and its ability to track adverse events to a particular manufacturer. It believes that a naming convention will provide another tool for identifying products. The FDA invites comments on the proposed names as well as designating suffixes for biologics. The comment period closes November 12, 2015.

MainStory: TopStory FDCActNews DrugBiologicNews SafetyNews

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