by Janelle Dumalaon
BERLIN, Dec 4 (APM) - Clinical studies of originator biological to biosimilar switching, used alongside post-market data, should be sufficient to allow pharmacists to switch branded biologicals for their near copies in some cases - a conference has heard.
"Controlled clinical trials" showing sustainability of efficacy and safety for the transition from reference drug to a biosimilar, used in conjunction with real-world data, could make biosimilar interchangeability at pharmacy level an acceptable option, Paul Chamberlain, from regulatory and health technology assessment consultancy, NDA Group told the DIA Biosimilars Conference in Berlin.
A periodic review of post-marketing authorisation data, such as from patient registries, showing that a biosimilar’s benefit-risk profile remains consistent with its reference biologic would be necessary for such a move, Chamberlain stressed.
His comments are unlikely to be greeted well by the branded industry and may even surprise generics companies which appear to be resigned to targeting only new patients for biosimilars without expectation of pharmacy substitution, regardless of how common place it is with compounds.
Still it is a step in the direction of greater use for biosimilars in a continent where Germany, for example, does not allow substitution of one biologic for another.
Speaking from the podium, Chamberlain noted methodologies for comparing biosimilars to reference biologics differed around the world. Bioanalytical assays - which characterise and assess stability of each manufactured batch of biologicals "are improved, but still not standardised," he said.
However, he said that more than interchangeability, "automatic substitution" will always be a stumbling block. Prescribing physicians will always want to be able to indicate that the product is not to be substituted if they do not want it to be, he said.
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