Congratulations go out to Amgen, which last week became the first company to receive US Food and Drug Administration (FDA) approval for a biosimilar of AbbVie’s Humira (adalimumab).
The firm announced the product is to be marketed under the brand name Amjevita, which, homophonically at least, is close Amgen’s own name, a choice which is fairly atypical in the pharma industry and even less so in the biosimilar space.
Bucking the biosimilar trend
Biosimilar makers have made it clear they want to avoid differentiating their copycats from originator product.
Recent FDA guidelines adding a random four-letter suffix to the international nonproprietary name (INN) of biologics were opposed by a number of companies, which viewed the move as an unnecessary layer of bureaucracy undermining the equivalent nature of a biosimilar product.
Amjevita appears to buck this trend, and if it deliberately references its sponsor then maybe it reflects Amgen’s unique position in the biosimilar market and its strategy going forward.
Other than confirming it “provided the brand name Amjevita for the Agency’s consideration,” Amgen did not offer any insight into its choice of name.
The firm has been challenged by the influx of first wave of biosimilars – versions of Neupogen and Epogen – and is set to lose market share through the second wave of products. Sandoz’s biosimilar of Enbrel (etanercept) was recently approved in the US, while Samsung Bioepis’ version has already been launched in a number of major markets.
Meanwhile, Amgen has been aggressively pursuing its own biosimilar pipeline with eight products in development on top of Amjevita.
Perhaps Amgen is attempting to leverage its reputation as a maker of originator biologics to promote the quality of the biosimilar, with the name Amjevita serving as a gentle reminder to both prescribers and payers.
A brazenly-named branded biosimilar would show Amgen’s intention in the market, and with its reputations as an originator drugmaker could instill confidence in the product from a physician’s point of view.
Incorporating a sponsor name is not unprecedented, Matthew Weinberg, CEO of regulatory consultancy The Weinberg Group, told us. “A firm can choose any name it wants and branding is important.”
“The key is for both the company and FDA to assure that pharmacists and consumers will not be confused by the name,” he added.
Thus the presence on the market of Pfizer’s penicillin injection ‘PfizerPen,’ Novo Nordisk’s insulin product ‘NovoLog,’ and Novartis’s octreotide acetate ‘Sandostatin’ which clearly reference the Swiss Pharma’s subsidiary Sandoz.
FDA rules OK
According to an FDA best practices document from 2014, “proprietary names should not incorporate the sponsor’s name across multiple products – e.g ‘ABCName1,’ ‘ABCName2,’ ‘ABCName3.’”
However, Appendix B suggests the uses of a sponsor’s name in the proprietary name could be considered misbranding.
“In determining the acceptability of the proprietary name, Amjevita, FDA thoroughly evaluated the proprietary name against potentially similar names of other products by assessing the phonetic, spelling, and orthographic similarities between the names that may lead to name confusion medication errors,” an FDA spokesman told us.
“The final determination on the acceptability of the proprietary name was based on FDA’s review of all information and analyses as described in the aforementioned draft guidance.”