In Japan, biosimilar guidelines, based on the European Union’s (EU) existing processes, were published by Japan’s Ministry for Health Labour and Welfare (MHLW) in March 2009 [1].

In June 2009, Sandoz received approval for its recombinant human growth hormone somatropin, the first biosimilar in Japan [1]. To date, the Pharmaceuticals and Medical Devices Agency (PMDA), Japan’s drug regulatory agency, has approved 27 biosimilars [2].

According to a report issued by ResearchAndMarkets, biosimilars launched in Japan now generate approximately Yen 32 billion (US$300 million) in sales and penetration is accelerating. In fact, their report predicts that in the next seven years, biosimilars will have a Yen 550 billion (US$5 billion) opportunity in Japan due to the patent expiry of a whole host of biologicals.

The report ¬– Japanese Biosimilars Landscape Study, 2009‒2020 – analyses the trends and requirements of regulatory approval for biosimilars in Japan. It also analyses the detailed biosimilar market for erythropoietin (EPO), filgrastim, pegfilgrastim and insulin separately from the opportunities of other key complex monoclonal antibody (mAb) biosimilars.

In August 2018, Kyowa Hakko Kirin gained approval for an ‘authorized’ biosimilar ‘version’ of originator darbepoetin alfa Nesp [3], the first darbepoetin alfa biosimilar approved in the country. This, according to the report, makes this a unique biosimilar landscape.

The report points to the less stringent regulatory environment for approval compared to the US, as well as the increasing healthcare burden and strong foothold of the biosimilar makers as having played key roles in the early uptake of biosimilars. In fact, uptake of biosimilars in the country is on a par with the market share of the best small molecule generics in Japan in a short period of time. Examples include Filgrastim BS, which has reached a volume share of ~45% in two years and Lantus BS (insulin glargine), which has reached a volume share of ~9% in two months. This compares well to Lipitor (atorvastatin) generics, which have an approximate 50% volume share.

The report also points to the MHLW’s announcement that it will update the biosimilars guideline by FY2020. This update has the aim of reducing the cost of development, as well as increasing physician confidence on the quality of biosimilars. According to ResearchAndMarkets, this is an ‘important weapon’ that can be used ‘to curb healthcare costs’ in Japan.

Related articles
CKD Pharma’s darbepoetin alfa biosimilar launched in Japan

Japan proving to be a favourable market for biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. Japanese guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Guidelines/Japanese-guidelines-for-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan
3. GaBI Online - Generics and Biosimilars Initiative. Japan approves first darbepoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/Japan-approves-first-darbepoetin-alfa-biosimilar

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