The development of ABP 710 was informed by the stepwise, TOE-based guidance from both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the demonstration of biosimilarity [4, 5]. The TOE for ABP 710 that resulted in its approval was comprised of evidence from analytical and pre-clinical studies demonstrating its structural and functional similarity to the reference product, as well as clinical studies confirming that there are no clinically meaningful differences in efficacy, safety and immunogenicity between the two [3]. ABP 710 was demonstrated to be similar to Remicade using state-of-the-art techniques that assessed structural and functional attributes of the molecule, including amino acid sequence, primary peptide structure, glycan mapping, purity, in vitro binding, effector functions and signalling pathways important for the mechanisms of action resulting in clinical efficacy in multiple indications of immune-mediated inflammatory disorders including IBD [6].

Clinical pharmacokinetic (PK) similarity of ABP 710 with Remicade sourced from the US and European Union (EU) was demonstrated in a randomized, single-blind, single-dose study in healthy volunteers following a single 5 mg/kg intravenous dose (n = 50 per treatment group, with assessments up to 50 days post dosing) [7]. As recommended by regulatory guidelines, the reference product for these studies was sourced from the US and EU such that comparisons could be made to assess the similarity of ABP 710 with both the US and EU products to support the establishment of the scientific bridge which would then allow for the use of a single source for the reference product in the subsequent comparative clinical study. Clinical similarity of ABP 710 with Remicade with respect to efficacy, safety and immunogenicity was confirmed in a randomized, double-blind, active-controlled, multiple-dose, comparative, 50-week study in patients with moderate to severe active RA with inadequate response to methotrexate, following 3-mg/kg infusions of ABP 710 or Remicade at predetermined intervals (n = 279 for each treatment group) [8]. In these clinical equivalence studies of ABP 710, safety and immunogenicity profiles were also found to be comparable, with similar incidence of treatment-related adverse events, similar incidence of rate of binding anti-drug antibodies (ADAs), and similar incidence of neutralizing ADAs in ABP 710 compared with Remicade.

Overall, the TOE supports the conclusion that ABP 710 is highly similar to Remicade and provided scientific justification for extrapolation to all approved indications of the reference product, including IBD, which is an indication not directly studied in the ABP 710 comparative clinical trial. The concept of extrapolation is unique to biosimilars and inherent to their abbreviated approval pathways. In the case of infliximab biosimilars, the abundance of real-world data supporting clinical equivalence of previously approved biosimilars in patients with IBD [9-12] should provide assurance of such extrapolation and further support the use of ABP 710 as an additional treatment option for patients with IBD.

Conflict of interest
The research study [3] was funded by Amgen Inc, Thousand Oaks, CA, USA.  For full details of the authors’ conflict of interest, see the research paper [3].

Abstracted by Dr Sonya G Lehto, Biosimilars, Amgen, One Amgen Center Drive, Thousand Oaks, CA, USA

Editor’s comment
Readers interested to learn more about biosimilar infliximab are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Biosimilar infliximab introduction into the gastroenterology care pathway in a large acute Irish teaching hospital: a story behind the evidence

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Extrapolation of indications in biosimilars: infliximab

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