FDA releases biosimilars labelling guidance
pharmafile | April 1, 2016 | News story | Manufacturing and Production, Medical Communications, Research and Development | FDA, biosimilars
The US Food and Drug Administration (FDA) has issued draft guidance on the labelling of biosimilar drugs.
The guidance states that the proposed biosimilar need only prove biosimilarity to the reference product during its clinical development, and that the reference branded biologic drug’s safety profile “may be relied upon to provide health care practitioners with the essential scientific information needed to facilitate prescribing decisions for the proposed biosimilar product’s labelled conditions of use.”
As biosimilars are derived from living organisms, they can only be highly similar, but never equal to, the reference biologic drug on which they are based. The FDA requires that “there are no clinically meaningful differences between the biological product and the reference 45 product in terms of the safety, purity, and potency of the product.”
The new guidance states that a biosimilar should be labelled in a similar way to a generic version of a branded drug, including clinical trial data to support the product’s safety and efficacy.
The safety and efficacy profile of the reference biologic is key, with the overall risk-benefit profile of the reference product, as found in clinical trials, being relevant to the biosimilar product. The FDA says that this is the case even if an adverse event or risk to the original has not been reported for the biosimilar; only the original.
The new guidance goes some way to clarifying the FDA’s position on biosimilar products, but further guidance documents are needed, including on interchangeability between reference biologics and their biosimilar equivalents. The FDA confirmed that it would provide clarity on this topic in the future, without giving a timeline.
Joel Levy
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