Draft Biosimilar Naming Guidance Hits the Street

 

FDA released its long awaited Guidance on naming of Biosimilar products (Nonproprietary Naming of Biological Products – Guidance for Industry [here]) today. In what is not too much of a surprise, especially after the first approved biosimilars name had a suffix (Zarxio, filigrastim-sndz), the FDA opted for most biosimilar products to have a suffix.  In addition, FDA is proposing to assign a suffix to the originator biologic products.  As FDA states in the draft Guidance:

FDA’s current thinking is that shared nonproprietary names are not appropriate for all biological products. There is a need to clearly identify biological products to improve pharmacovigilance and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable. Accordingly, for all biological products, FDA intends to designate a nonproprietary name that includes a suffix composed of four lowercase letters. Each suffix will be incorporated in the nonproprietary name of the product. This naming convention is applicable to biological products previously licensed and newly licensed under section 351(a) of the PHS Act or 351(k) of the PHS Act, as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).

The Guidance indicates FDA’s intent to also assign suffixes to newly licensed standalone biologic products, as well as certain previously approved standalone biologic products.

The Agency does ask for comments relative to whether those biosimilar products that have been demonstrated to be interchangeable should also have a suffix or share the same suffix as the reference biologic product.   FDA indicates that it believes its suffix naming proposal will:

  • Minimize inadvertent substitution of products that FDA has not determined to be interchangeable.
  • Aid in the collection of specific and accurate pharmacovigilance data.
  • Encourage use of suffix in ordering and recording and prescribing practices to assure the intended product is obtained.
  • Avoid inaccurate perceptions of safety and effectiveness based on the product’s licensure pathway

The Agency notes that, in developing this draft Guidance, it has taken into consideration comments from stakeholders and says:

In implementing the BPCI Act, FDA has carefully considered the appropriate naming convention to maximize the success of biosimilar products and interchangeable products and to help ensure the safety of patients receiving biological products licensed under the PHS Act.

The Guidance also provides insight into Agency thinking relative to the following:

  • Related biologic products may be approved for different indications.
  • Biosimilar products may be licensed for fewer than all indications.
  • Related biologic products or biosimilar products may be approved for different routes of administration and have different delivery configurations.

Such issues could impact the proper intended use or function of a product and could actually result in a medication error if the wrong product were dispensed.  This parallels the “functionality” concerns expressed by CDER management, relative to differences in generic products which led to a guidance on size and shape of generic products (see previous post here ). The Guidance does reference the Agency’s concern that the principles of generic substitution are so ingrained in the healthcare system that this naming departure may make providers more aware of subtle differences that may be relevant among products.

Clearly, the designation of a suffix and use of the same suffix as the reference biologic product for interchangeable products will provoke some interesting comments and raise questions from industry and the public.  For instance, if a suffix that is currently used designates an abbreviation that relates to a company name, how can that suffix be used for another firm’s product?  If a company obtains licensure for a biosimilar that has a suffix that differs from the reference biologic product, but later obtains supplemental approval for interchangeability, will they have to change their name and what impact will that have on the biosimilar company?  What period of time will they be given to change the suffix to that of the reference product?  Will the delay disadvantage the biosimilar company?  These are just a few of the questions and comments we may expect to be submitted in response to the draft Guidance.