Extrapolation of indications for biosimilars in Japan

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In his presentation at the 14th Annual Biosimilars Group Conference, Dr Daisaku Sato, Director, Office of Cellular and Tissue-based Products at the Pharmaceutical and Medical Devices Agency (PMDA), discussed extrapolation* of indications for biosimilars in Japan [1].

Quality, similarity and safety V13D12

The PMDA’s position is that if the efficacy of the biosimilar has been demonstrated to be comparable to the reference product in one of the indications and comparable pharmacological effects are also expected in other indication(s), it may be possible to extrapolate from one indication to other indication(s) of the reference product.

The PMDA expects the following to also be considered in order to justify the extrapolation:
• comprehensive physicochemical assays and biological assays (in vitro pharmacological assay)
• safety of the biosimilar in ‘extrapolated’ indications.

In the example of infliximab BS, a comparative study between the biosimilar and its reference product (Remicade) was carried out in rheumatoid arthritis. The indications of Crohn’s disease and ulcerative colitis were then also approved as extrapolated indications. For the psoriasis indication additional data was required. While for intractable uveoretinitisin Behcet’s disease and ankylosing spondylitis the biosimilar has not yet been authorized.

According to Japanese regulation, indications beyond the exclusivity period of the originator’s approval can only be extrapolated for the biosimilar, indication by indication. For infliximab BS, this means that the marketing application and approval of further indications can be re-examined until the end of the exclusivity period for the specific indication, e.g. for Behcet’s disease up to July 2018.

The European Medicines Agency’s position on extrapolation of indications for biosimilars is that ‘if clinical similarity can be shown in a key indication, extrapolation of efficacy and safety data to other indication(s) of the reference product may be possible’ under certain conditions [2].

*Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition.

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

Biosimilars: extrapolation of clinical use to other indications

Investigating the validity of biosimilar extrapolation and interchangeability

GaBI Journal is indexed in Embase, Scopus, Thomson Reuters’ ESCI, and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

If you would like to receive a PDF copy* of the Daisaku presentation [1], please send us an email.

*For profit organizations subjected to a fee

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1. Daisaku S. Surfing the wave in Japan for regulatory convergence of biosimilar. 14th Annual Biosimilar Medicines Group Conference; 28-29 April 2016; London.
2. GaBI Online - Generics and Biosimilars Initiative. Efficacy, extrapolation and interchangeability of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 14]. Available from: www.gabionline.net/Biosimilars/Research/Efficacy-extrapolation-and-interchangeability-of-biosimilars

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