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 The leading web portal for pharmacy resources, news, education and careers September 19, 2017
Pharmacy Choice - Pharmaceutical News - New Findings from G.R. Woollett and Colleagues Has Provided New Data on Biosimilars (A 'Global Reference' Comparator for Biosimilar Development) - September 19, 2017

Pharmacy News Article

 9/13/17 - New Findings from G.R. Woollett and Colleagues Has Provided New Data on Biosimilars (A 'Global Reference' Comparator for Biosimilar Development)

By a News Reporter-Staff News Editor at Biotech Week Fresh data on Drugs and Therapies - Biosimilars are presented in a new report. According to news reporting originating from Washington, District of Columbia, by NewsRx correspondents, research stated, "Major drug regulators have indicated in guidance their flexibility to accept some development data for biosimilars generated with reference product versions licensed outside their own jurisdictions, but most authorities require new bridging studies between these versions and the versions of them licensed locally. The costs of these studies are not trivial in absolute terms and, due to the multiplier effect of required repetition by each biosimilar sponsor, their collective costs are substantial."

Our news editors obtained a quote from the research, "Yet versions of biologics licensed in different jurisdictions usually share the same development data, and any manufacturing changes between versions have been justified by a rigorous comparability process. The fact that a biosimilar is usually expected to be licensed in multiple jurisdictions, in each case as similar to the local reference product, confirms that minor analytical differences between versions of reference biologics are typically inconsequential for clinical outcomes and licensing. A greatly simplified basis for selecting a reference comparator, that does not require conducting new bridging studies, is proposed and justified based on the shared data of the reference product versions as well as the proof offered where biosimilars have already been approved."

According to the news editors, the research concluded: "The relevance of this proposal to the interchangeability designation available in the US is discussed."

For more information on this research see: A 'Global Reference' Comparator for Biosimilar Development. Biodrugs, 2017;31(4):279-286. Biodrugs can be contacted at: Adis Int Ltd, 5 The Warehouse Way, Northcote 0627, Auckland, New Zealand (see also Drugs and Therapies - Biosimilars).

The news editors report that additional information may be obtained by contacting G.R. Woollett, Avalere Inc, FDA Regulatory Strategy & Policy, Washington, DC 20036, United States.

Keywords for this news article include: Washington, District of Columbia, United States, North and Central America, Drugs and Therapies, Genetically-Engineered Proteins, Genetic Engineering, Bioengineering, Biotechnology, Biosimilars, Biologics.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2017, NewsRx LLC



(c) 2017 NewsRx LLC

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