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FDA Releases Guidance Document for Naming Biologics

January 20, 2017
The US Food and Drug Administration (FDA) has released a new guidance document recommending a new naming system for current and future biological products.

The US Food and Drug Administration (FDA) has released a new guidance policy for naming current and future biological products licensed under the Public Health Service Act (PHS).1

According to the FDA, products from now on will be required to bear a nonproprietary name, which will consist of a proper name containing the core name of the product along with a distinguishing suffix of 4 random lowercase letters.

Biologics are often used in cases of severe rheumatoid arthritis.Biologics are often used in cases of severe rheumatoid arthritis.

The new naming policy comes at a time when the market for biological medicines is expanding increasingly. With the introduction of biosimilar products and numerous pipeline novel therapies, the FDA now intends to re-establish naming rules for all current and future biologicals licensed under section 351(a) or 351(k) of the PHS Act.

The naming system currently does not apply for interchangeable drugs, however. The FDA is now considering developing a rulemaking process to address how interchangeable drugs will be labeled as well, according to Sandy Walsh, a media affairs representative for the agency.

FDA's Intention

The FDA’s intention is to use this naming system so products containing related substances to reference products can be easily identified, especially when efforts to ascertain a specific product are unsuccessful and related products must be identified. “Further, distinguishing suffixes should help minimize inadvertent substitution of any such products that have not been determined to be interchangeable,” the FDA wrote in its guidance document.

However, the guidance document is not enforceable by law, but rather serves as a current recommendation to companies. The FDA is still determining how it will create suffixes for future products and is intending to implement this for current products, as well.

In the near term, a limited group of products will be assigned suffixes. Indeed, some of the more recently approved biosimilars, including Erelzi (etanercept-szzs) and Amjevita (adalimumab-atto), feature this suffix.

Biological products licensed under the PHS act also include:

  • Therapeutic protein products
  • Vaccines
  • Allergenic products
  • Blood derivatives

With the implementation of the Biologics Price Competition and Innovation Act (BPCI), the FDA established an abbreviated licensure pathway for biosimilar and interchangeable products. Because this legislation will further expand the biological market with products related to brand name biologics currently on the market, the hope is this naming convention will benefit doctors and patients in distinguishing these products and ensuring robust identification and tracking.

“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 FDA stated.

Click here to read the guidance document.

Last updated on: January 20, 2017
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