Biosimilars in Japan: an overview

Biosimilars/Research | Posted 09/07/2021 post-comment0 Post your comment

No regulations on interchangeability exist in Japan and switching between a reference product and biosimilar is often impractical, according to a letter recently published in The Lancet Oncology [1].


Following a review of biosimilar epoetin in the EU, Japan and the US [2], a reply has been published regarding the status of oncology biosimilars in Japan. Epoetin is an erythropoiesis-stimulating agent used to increase the production of red blood cells in conditions such as chronic kidney disease and chemotherapy-induced anaemia. The first biosimilar epoetin was approved in the US in 2018, however, price and safety considerations have been barriers to uptake.

The recent commentary by Nagai S from Japan [1] explains that the first epoetin biosimilar was approved in Japan in 2010 for the treatment of renal anaemia and anaemia of prematurity, which affects some pre-term babies and is caused by a decrease in erythropoietin. Chemotherapy-induced anaemia, however, was not included as an indication.

In Japan, all oncology biosimilars are administered by hospitals, which can decide whether they use biosimilars or the reference product. Guidelines on oncology biosimilars are published by professional oncology societies. For example, the Japanese Breast Cancer Society’s clinical practice guidelines for breast cancer (2018) state that the quality, efficacy and safety of biosimilars has been shown and that biosimilars can contribute cost savings. The Japan Society of Clinical Oncology also recommended the use of biosimilar filgrastim, which is used to stimulate the production of neutrophils following chemotherapy, because it has equivalent efficacy and safety to the reference product.

The author also makes more general points regarding the status of biosimilars in Japan. The author explains that biosimilars in Japan are approved by the Pharmaceuticals and Medical Devices Agency (PMDA). The PMDA guidelines on the quality, safety and efficacy assurance of follow-on biologicals was first issued in 2009 and revised in 2020. The updated guidelines state that comparative pharmacokinetic and clinical efficacy studies are needed for a biosimilar to be approved. However, the PMDA does not make its review reports and drug labels publicly available; or publish class-specific biosimilar guidance.

There are no regulations on interchangeability, which refers to the replacement of a reference product with a biosimilar by a pharmacist without the approval of the prescriber [3], in Japan. Switching between reference products and biosimilars, which is decided by a physician, is permitted in Japan. However, switching is usually impractical for physicians, pharmacists, and patients in Japan. This is partly because biological drugs must be ordered by their precise name and the non-proprietary name of biosimilars in Japan differ from the reference product by an additional word such as biosimilar, and all oncology biosimilars are currently administered in hospitals, the author explains.

Conflict of interest
The author of the commentary [1] reports receiving personal fees from pharmaceutical companies.

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1. Nagai S. Current situation of oncology biosimilars in Japan. Lancet Oncol. 2021;22(3):e82.
2. Bennett CL, Schoen MW, Hoque S, et al. Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions. Lancet Oncol 2020;21: e575–88.
3. GaBI Online - Generics and Biosimilars Initiative. Different approaches to the interchangeability of biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jul 9]. Available from:

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