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EuropaBio calls for distinguishable names for biosimilars despite potential of big savings Posted 28/11/2014

On 6 November 2014, the European Association for Bioindustries (EuropaBio) published a new guide and a new position paper on biosimilars in Europe. EuropaBio expects these two documents to contribute to the policy debate on key issues regarding biosimilars among European and national regulators, policymakers, physicians, other healthcare providers, and patients.

The guide, entitled ‘When Science Meets Policy’, provides basic facts about biologicals, including biosimilars, and explains why Europe needs to continue to maintain high standards for biosimilars.

Both documents highlight EuropaBio’s opinion on the need for distinguishable non-proprietary names for all biologicals. The European trade group believes that this will ‘enhance traceability, providing transparent information in biosimilar product labels, facilitating physician and patient understanding as well as respecting physicians’ prescribing authority’.

Advocates for the use of a common name or the same international non-proprietary name for biosimilars are concerned that there could be the possibility of overdosing or misdosing if different names were used, as a patient could inadvertently be prescribed two versions of the same biosimilar [1].

European Union legislation currently requires biologicals to be identified through the recording of brand name and batch number. The European Generic medicines Association (EGA) also points out that ‘biosimilar medicines have been used safely since 2006, and pharmacovigilance data shows that current tracking and adverse event reporting systems work well’ [2].

Biosimilars typically deliver 20−30% discounts on the originator biological. Despite a slow start, biosimilars could cut health spending in Europe by US$11−33 billion by 2020, according to a Thomson Reuters report. While in the US, introduction of biosimilars of the granulocyte colony-stimulating factors filgrastim, which is currently pending FDA approval, and pegfilgrastim have been estimated could reach US$1.8 billion in the US by 2023. However, using different names for biosimilars, it is thought by some, could impact on the use of biosimilars, reducing any potential savings.

In order to better understand the impact biosimilars could have on the European market Ipsos Healthcare has launched a study, which will survey 650 rheumatologists, dermatologists, and gastroenterologists across France, Germany, Italy, Spain, and the UK. The study will evaluate the intent of physicians to prescribe biosimilars across seven autoimmune indications (Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, psoriasis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis).

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References
1.   GaBI Online - Generics and Biosimilars Initiative. FDA’s public hearing on biosimilars draft guidances [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 28]. Available from: www.gabionline.net/Biosimilars/General/FDA-s-public-hearing-on-biosimilars-draft-guidances 
2.   GaBI Online - Generics and Biosimilars Initiative. Biologicals in EU to be identified by brand names [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 28]. Available from: www.gabionline.net/Policies-Legislation/Biologicals-in-EU-to-be-identified-by-brand-names

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Source: EuropaBio, Ipsos, Reuters

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