PhRMA, BIO Double Down on Biosimilar Naming With FDA Petition

Regulatory NewsRegulatory News | 21 January 2016 |  By 

The nontrivial issue of how biosimilars should be named in the US may not go away until the US Food and Drug Administration (FDA) makes a definitive decision on how these new products should be labeled and tracked.

On the one hand, these cost-saving biosimilars will need to be clearly distinguished from their reference product so that regulators can track any adverse events and ensure they are safe, though on the other side of the coin, any new labeling requirements could lead to unwarranted safety concerns among physicians and patients, which would hamper uptake and mean higher costs.

For their part, industry groups Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) are showing no signs of letting up on their push to influence how biosimilars are named, particularly with their recent FDA petition outlining specific requests on what the labels should include.


In August, FDA released draft guidance on the nonproprietary naming of biosimilars and biologics, outlining how it would attach unique but meaningless suffixes to biosimilars (ie., "replicamab-cznm"). The agency explained that this new system would "help prevent inadvertent substitution of biological products" and support pharmacovigilance efforts, ensuring biologics and related biosimilars are easily distinguishable and that adverse events can be tracked.

Industry groups commenting on the guidance, including the Biosimilars Forum, PhRMA and BIO, supported FDA's proposal, but called for the agency to use "meaningful" and "distinguishable" suffixes linked to the license holder's name, just like what was used for the only US-approved biosimilar from Sandoz, known now as Zarxio (filgrastim-sndz).

However, the Generic Pharmaceutical Association's (GPhA) Biosimilars Council opposed FDA's proposal, claiming that "adding a suffix … is unnecessary and does not achieve the Agency's stated goals as it will lead to confusion among prescribers and patients." Their comment goes on to argue that these products "have other names … for distinct recognition; including a brand name, company name, a lot number and a national drug code (NDC) number that readily distinguish [them] from other products."

Insurers such as the Kaiser Foundation, CVS Health and America's Health Insurance Plans (AHIP) fell in line with the Biosimilars Council's stance, opposing the use of a suffix in favor of other measures to distinguish biosimilars for pharmacovigilance purposes.

PhRMA/BIO Petition

Now, PhRMA and BIO seem to be taking their push to make biosimilars as distinguishable as possible a step further, calling on FDA to include information stating that a biosimilar must not only say “biosimilar” on its label but also identify the reference product.

The groups even go so far as to call for biosimilar labels to describe the basis of approval for each indication with relevant data for the reference product and biosimilar.

“Specifically, biosimilar labeling should include the relevant nonclinical and clinical data supporting the finding of biosimilarity and identify whether the described studies were conducted with the biosimilar or reference product,” the petition says.

For example, the groups point to the labeling of Sandoz’s Omnitrope (somatropin [rDNA origin] for injection), a follow-on protein product approved under a section 505(b)(2) application. Omnitrope’s application referenced Pfizer’s listed drug Genotropin (somatropin [rDNA origin] for injection). The Omnitrope labeling distinguishes the reference product, referring to Genotropin as another somatropin product.

“A comparable approach is appropriate for biosimilars given their similarities to follow-on protein products,” PhRMA and BIO claim.

And like a number of states finalizing substitution laws that require FDA to determine if a biosimilar is interchangeable before pharmacists can make the switch for patients, PhRMA and BIO are calling for biosimilar labels to say whether the product is interchangeable and can be substituted by a pharmacist without physician approval.

FDA has 180 days to respond to this petition.

Citizen Petition from PhRMA and BIO



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