The company recognizes that it has been a busy period in the world of biosimilars and sees as positive that many emerging countries are in the process of developing or implementing regulatory pathways for the approval of biosimilars, using the World Health Organization (WHO) guidance document as a reference. 

On the issue of naming Roche’s position is that ‘patient safety is of paramount importance. So Roche and other companies believe that all biopharmaceutical medicines need to be identifiable throughout the prescribing and dispensing processes, a practice that would not be possible under the current International Nonproprietary Name (INN) system if biosimilars were to use the same INN as the innovator product’.

Roche therefore expressed its support for the WHO’s proposal to use a unique global ‘biological qualifier (BQ)’ for biosimilars [1]. Dr Fermín Ruiz de Erenchun, Global Head Biologic Strategy Team at Roche says that ‘a unique and universally available identifier system could ensure that all approved biopharmaceutical medicines are individually identifiable’.

Roche believes that ‘the best way to improve the outlook for patients is to keep developing innovative medicines and diagnostics’. The company points to the fact that they have ‘developed nine innovative cancer medicines which have been proven to improve and, in many cases, extend the lives of people with 12 common cancer types’.

Roche, while acknowledging that biosimilars can enhance competition and provide savings to healthcare systems, states that ‘patient safety must be the first priority for all products’. Dr Fermín adds that ‘this assurance can only be had when products have been subject to thorough and extensive analytical, non-clinical and clinical comparative assessments and if there are well-regulated processes in place’.

Roche ends its statement with a definition of two key terms: biosimilar, for which it refers to the European Medicines Agency; and ‘non-comparable biological products’, for which Roche refers to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) policy statement of July 2014. In this statement the IFPMA proposes this term ‘to describe those biotherapeutic medicinal products that are intended to ‘copy’ another biotherapeutic product; have not been directly compared and analyzed against an already licensed reference biotherapeutic product; and have not been approved via a regulatory pathway that is in alignment with World Health Organization Similar Biotherapeutic Product guidelines that ensure quality, safety, and efficacy’.

Editor’s comment
For GaBI Online’s definition of biosimilar, non-originator biological and other terms surrounding biosimilars please see the GaBI Online glossary of key terms [2].

Related article
WHO investigates use of a biological qualifier for biosimilars

References
1.   GaBI Online - Generics and Biosimilars Initiative. WHO proposal offers clarity for biosimilar nomenclature [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/General/WHO-proposal-offers-clarity-for-biosimilar-nomenclature
2.   GaBI Online - Generics and Biosimilars Initiative. Glossary of key terms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/General/Glossary-of-key-terms

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