FDA on interchangeability and demonstrating biosimilarity

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FDA on interchangeability and demonstrating biosimilarity

Home/Guidelines | Posted 16/09/2016 0 Post your comment

The US Food and Drug Administration (FDA) intends to clarify its expectations for demonstrating the interchangeability of biosimilars with their reference biologicals, according to Dr Steven Kozlowski, Director of the Office of Biotechnology Products at FDA.

In his presentation at the 2016 Generic Pharmaceutical Association (GPhA) Biosimilars Council Conference, which was held in North Bethesda, MD, USA on 7−8 September 2016, Dr Kozlowski outlined the agency’s view with respect to biosimilarity and interchangeability.

FDA finally published its two overarching guidance documents on scientific and quality considerations in demonstrating biosimilarity in April 2015. Since then, the agency has also produced other guidance documents and draft guidances covering other subjects relevant for biosimilars [1].

According to Dr Kozlowski, FDA expects to issue draft guidances on both biosimilarity and interchangeability in the near future, including the following:
• Considerations in Demonstrating Interchangeability to a Reference Product
• Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

However, on the subject of interchangeability, Dr Hillel Cohen, Executive Director of Scientific Affairs at Sandoz Biopharmaceuticals, said that ‘approval for a biosimilar that can be substituted for its reference product will probably hinge on clinical data that evaluate several switches between the products’. He added that ‘non-medical switching’ is merely a buzzword and does not apply to biosimilars. Concerning the problem of unwanted immunogenicity for biosimilars, he clarified that the ‘theoretical concern is far, far less than what existed for the reference product when the reference product was first approved’.

Dr Kozlowski stated that the agency would also host webinars and presentations at professional society and clinical specialty meetings. FDA will also continue to meet with sponsors and interact with other regulatory agencies.

Related article
FDA and biosimilars: update on key themes

Reference
1. GaBI Online - Generics and Biosimilars Initiative. US guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 16]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-biosimilars

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Source: GPhA