Safe switching for biosimilars

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Five principles to address the four key considerations for biosimilar interchangeability were presented by Dr Brad Jordan, Director of Global Regulatory and R & D Policy at Amgen at an annual biosimilars conference [1]. The third of these principles is that clinically relevant evidence of safe switching for biosimilars is required.

Substitution V13F14

According to Dr Jordan, issues associated with safe switching for biosimilars include:

  • The risks of switching to or between biosimilars are not identical between product classes or products
  • Chronically administered biosimilars may require more evidence than biosimilars used shorter term due to immunogenicity considerations

1. One-time transition studies were incorporated into the development of US-licensed anti-tumour necrosis factor (anti-TNF) biosimilar Remicade (CT-P13). Celltrion reported that studies carried out in nearly 600 inflammatory bowel disease (IBD) patients in eight countries show comparable efficacy and safety following a switch to biosimilar infliximab from originator infliximab [2].

2. ‘NOR-SWITCH’ post-approval one-time switching study for biosimilar infliximab in Norway. Results of this two year-long phase IV study have shown that Celltrion’s infliximab biosimilar (Remsima, CT-P13) is not inferior to the originator biological Remicade [3].

Policy considerations
Dr Jordan believes that the following need to be taken into account when considering safe switching for biosimilars:

  • For biosimilar products administered multiple times there should be clinically relevant evidence that switching to a biosimilar is appropriate

The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has stated that ‘for biotherapeutics that typically are administered multiple times in the course of treatment, the interchangeability designation should be justified including clinically relevant evidence that switching or alternating between the SBP [similar biotherapeutic product] and RBP [reference biotherapeutic product] would not impact safety or efficacy’.

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Biosimilarity does not mean extrapolation of all indications

Biosimilarity is not interchangeability

1. Jordan B. Regulatory implications for implementing biosimilar interchangeability: addressing policy and practical concerns. SMi 3rd Annual Biosimilars USA Conference; 16-17 November 2016; Iselin, New Jersey, USA.
2.  US Food and Drug Administration. Center for Drug Evaluation and Research. Division Director Review: BLA 125544 for CT-P13, a proposed biosimilar to Remicade (infliximab) [homepage on the Internet]. [cited 2017 May 5]. Available from:
3.  GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator []. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 5]. Available from:

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