Comments made at the US Food and Drug Administration’s (FDA) recent meeting on biosimilars included a call for interchangeability information in the Purple Book, criticism of FDA’s use of arbitrary suffixes and a request to waive bridging studies for biosimilars.
FDA held its meeting on ‘Facilitating Price Competition and Innovation in the Biological Products Marketplace’ on 4 September 2018. The aim of the public hearing was to receive comments on the FDA’s approach to enhancing competition and innovation in the biologicals market, including by facilitating greater availability of biosimilar and interchangeable products.
Several drugmakers, including Janssen, Novo Nordisk and Genentech, urged FDA to include additional information on interchangeable products in the agency’s Purple Book.
The Purple Book is a set of lists of licensed biological products and biosimilars that is meant to be the biological equivalent of the ‘Orange Book’, which lists pharmaceuticals and their generics equivalents. The agency last updated the Purple Book for biologicals and biosimilars in February 2017 [1].
The drugmakers suggest that the listing of patents should be required, as is the case in the Orange Book. It was also suggested that the agency highlight indications for the reference product for which the biosimilar is not approved and include a description or list of pivotal clinical trials considered in FDA’s approval of the biosimilar. In addition, they suggest that the following language be added to the Purple Book:
‘FDA has determined that it is safe to switch patients from a reference product to an interchangeable product, and the laws in many states permit substitution of interchangeable products for their reference products at the pharmacy level under certain conditions (check your state's laws and regulations). FDA has not made such a determination about a product approved as a biosimilar; pharmacy-level substitution is not advised and may be illegal under state law. In addition, FDA does not make such determinations regarding switching between two or more biosimilar products, whether interchangeable or not, and often there are little or no data regarding such switches.’
In their comments, Mylan and Novartis criticized FDA’s use of arbitrary suffixes in its naming of biologicals. They ‘believe FDA's naming convention for non[-]proprietary names of biologic[al]s is unnecessary for the purported reason of increased patient safety’. Moreover, they ‘believe such suffixes do not provide additional value beyond that of the current naming system, which has been used successfully for over six decades’.
The companies claim that the agency’s naming convention, which was introduced in January 2017 [2] ‘has created significant and serious challenges’ for pharmacovigilance and is reducing the uptake of biosimilars. They therefore recommend that the agency reviews pharmacovigilance data and ‘if the data reveals that pharmacovigilance has been negatively impacted, the agency should place the interests of patients first and reverse the decision to add suffixes to the non-proprietary name of biologic[al]s’.
FDA’s final guidance on non-proprietary naming for biologicals assigns a non-proprietary name for all originator biologicals, related biologicals and biosimilars that includes an ‘FDA-designated suffix’. The ‘proper name’ consists of a combination of the ‘core name’ and distinguishable suffix, which will be ‘devoid of meaning’ and be ‘composed of four lowercase letters’ [2].
Finally, the International Generic and Biosimilar Medicines Association (IGBA) suggested that FDA waive bridging studies for biosimilars. The IGBA proposes ‘that a bridge between the foreign and local reference products be established without any additional bridging studies as long as certain criteria are met’. This it says will ‘avoid unnecessary, and therefore unethical, clinical bridging studies’, as well as ‘avoid the multiplication of bridging studies by different sponsors’ for the same reference biological and ‘increase the efficiency of biosimilar development’.
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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA updates Purple Book for biologicals and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 12]. Available from: www.gabionline.net/Biosimilars/General/FDA-updates-Purple-Book-for-biologicals-and-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 12]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals
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Source: Federal Register, Janssen, Novartis, US FDA
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