In a Petition filed on September 19, 2013 (here),  GPhA requests that the FDA:

  • Implement its INN naming policy equally to all biologics; and
  • that because all biologics approved under the Section 351(k) pathway (that section of the act that governs the approval of biosimilar products) are “highly similar”; and thus, have no clinically meaningful differences from the reference protein product (RPP) that they share the same INN as the RPP, just as comparable originator products produced by a change in a manufacturing process or change in facility (post-change product) share the same INN as the original RPP (pre-change product).

GPhA goes on to say, in pertinent part, that this is essential to assure the intent of the Biologics Price Competition Act, enacted in March  2010, is not thwarted, in that different INN names and/or different established names for such “highly similar products” would likely cause more confusion in the marketplace, adversely impacting safety relative to adverse drug event (ADE) reporting/evaluation, and would negatively impact cost savings to consumers and decreasing the public’s perception of the “similarity” and/or clinical performance of such products, even when the FDA approves them as “highly similar” and concludes that the biosimilar does not have clinically  meaningful differences from the RPP.  In addition, the Petition states that adopting differing names for the same RPP “would disrupt the current global naming system.”

To support its position, GPhA mentions a list of FDA approved products for which there are multiple RPPs by different manufacturers, using different manufacturing processes, yet these RPPs have the same INN and established names.  This is also true for biosimilars approved in the European Union where such products do have the same INN and established names.  Why, then, should biosimilars in this country be treated any differently?  GPhA also mentioned that one product, Remicade® (infliximab), has undergone at least “37 manufacturing changes post-approval”, yet comparability was sufficient so that the product was deemed interchangeable with no concomitant change in the INN or established name.

The GPhA petition runs through the issue raised by biologic companies relative to ADE reporting, but concludes that having separate names for highly similar products would silo or “limit the investigation to one manufacturer when all biosimilar products need to be considered.”

One can see why the biologic industry, as it exists today, would choose to protect its franchise products by minimizing the impact of biosimilars.  However, it is like a Hatch-Waxman déjà vu, all over again (to use a Yogi Berra-ism), to raise doubt in the minds of consumers and healthcare practitioners about the performance of highly similar products in a battle to retain market share.  Well, GPhA is onto something and they appear to be on target with their comments and requests, which appears to be in tune with the actual intent of the biosimilar legislation passed by Congress – let’s make these drugs safe and effective and more affordable, and give the FDA credit for assuring that they will not be approved until they meet the rigorous standards that the Agency is imposing.   It appears to be working well in Europe; let’s  give the FDA a chance to provide the entire healthcare community the same benefits for biosimilars we have seen work so well for small molecules.   As GPhA notes in its petition:

“Consistent biosimilar naming aligns with previous FDA recommendations.  In 2006, FDA issued a policy paper to the World Health Organization (WHO), supporting the original purpose of the INN, to identify active ingredients, and reject the use of non-proprietary names to communicate interchangeability.” Let’s hope FDA and stakeholders can reach the same conclusions today!

For this and all questions related to biosimilars, please contact Joan Janulis, Vice President, Lachman Consultants, at