FDA Releases Long Awaited Guidance On Biosimilars Naming

By Anna Rose Welch, Editorial & Community Director, Advancing RNA

After months of debate between reference product makers and generic manufacturers, the FDA released its long-awaited guidance proposing a naming strategy for biosimilars — and the decision has left some on the generics side flustered. While the FDA originally deemed the WHO’s previous naming proposal a “placeholder,” the agency has taken a similar approach in its own policy. Biosimilars will share the same international non-proprietary name (INN) as their reference product, in keeping with generic manufacturers’ demands. However, in favor of reference makers’ wishes, this INN will be followed by a four-letter suffix which will be unique to each biosimilar product and will be “devoid of meaning.”

In the case of drugs that have previously been licensed, the agency has proposed a rule to assign suffixes to several already-approved biologics, including filgrastim, pegfilgrastim, infliximab, and epoetin alfa, The FDA Law Blog says. In the case of Sandoz’s soon-to-be-released filgrastim, the agency plans to change the current four-letter suffix sndz to one that does not have any ties to the manufacturer. (According to Regulatory Affairs Professionals Society (RAPS), however, the agency is still considering the possibility of using four-letter suffixes based on a product’s manufacturers name.)

Like the WHO policy, the FDA’s guidance, announced last week in the FDA Voice, is an attempt to meet in the middle of reference and biologics makers’ arguments. However, from the generics makers’ points of view, reference makers got their wish. The tacking on of a suffix essentially differentiates the biosimilar from the reference product and supports the notion that a biosimilar is only “similar” and should be treated as such. In line with brand makers’ concerns, the agency has asserted the suffixes will help doctors and pharmacists ensure they’re prescribing the appropriate drug when the biosimilar is not interchangeable. The move to include the suffix also supports reference product makers’ arguments that there needed to be a more established system for pharmacovigilance and adverse event reporting.

So far, the new proposal has received mixed reviews. The Biologics Prescribers Collaborative has spoken out in favor of the ruling, claiming that, “Those prescribers who work every day with biologics — and their patients — are the winners from the FDA’s decisions. BPC has strongly advocated for distinguishable names because it is consistent with the science, reflecting that no two biological products can be the same.”

However, the Biosimilars Council (a division of the Generic Pharmaceutical Association (GPhA) is not hiding its disappointment with the FDA’s decision. In a statement released by the Biosimilars Council, Dr. Bertrand Liang states, “Shared INNs without suffixes are…safely and effectively utilized in EU, Canada, Australia, and Japan. Adding a random collection of letters to the product’s nonproprietary name confers no additional safety benefit, and in fact would require the healthcare professional to be armed at all times with a code-breaking reference.” Liang goes on to say that this move could construct barriers to biosimilar cost-savings, as prescribers will not be able to easily identify how biosimilars and reference products relate to each other.

There is perhaps one area biosimilars makers could have their demands met, and that’s in the case of interchangeable biosimilars. The FDA chose not to propose a policy for naming a biosimilar that is allowed to be substituted for the reference product. Therefore, it is asking industry to provide its opinion on whether the biosimilar should be labeled with a different four-letter suffix than the reference product, or if the biosimilar should share the same suffix as the reference.

As this guidance is currently a draft, industry members have a chance to offer feedback, especially in regards to how the FDA should go about labeling biosimilars that are deemed interchangeable with their reference drug. The comment period on the draft guidance and proposed rule will conclude on October 27 and November 2, respectively.