Three darbepoetin alfa biosimilars approved in Japan

Biosimilars/News | Posted 04/10/2019 post-comment0 Post your comment

Three pharmaceutical companies have announced approval of their anaemia treatments for sale on the Japanese market, while Mochida reveals it will sell the first teriparatide biosimilar in the country.

Anaemia 2 V13J18

The Japanese biosimilars market is growing rapidly. The government has invested heavily in biosimilars, leading analysts to predict an average growth of 40% per year in the Japanese biosimilars market from 2017 to 2021.

September 2019 alone has seen three darbepoetin alfa biosimilars approved in Japan. Darbepoetin alfa stimulates the production of red blood cells (erythropoiesis). It is used to treat anaemia, which commonly occurs in patients receiving chemotherapy or experiencing kidney failure.

Japan-based JCR Pharmaceuticals (JRC) has developed a long-acting injectable version of the drug in collaboration with Kissei Pharmaceuticals (Kissei), which is also Japan-based. The two companies began a collaborative agreement in September 2013 and have conducted a phase III study demonstrating equivalent efficacy and safety compared with the reference product. JCR will manufacture the product, while Kissei will manage medical information and marketing. The companies have previously worked together on an epoetin alfa injectable, which also stimulates red blood cell production.

Two other darbepoetin alfa biosimilars have also been approved, from South Korean firms Chong Kun Dang (which will be distributed via Mylan’s Japanese arm) and Dong-A ST (with their Japanese partner Sanwa Kagaku Kenkyusho).

The first darbepoetin alfa biosimilar was approved in Japan in 2018 [1]. The market for the drug in Japan is sizeable; over 330,000 patients in Japan are estimated to be undergoing chronic dialysis, the majority of which receive treatment with erythropoiesis-stimulating agents.

In other news, Mochida Pharmaceuticals (Mochida), working with Hungarian multinational Gedeon Richter (Richter), has also announced marketing approval for a teriparatide biosimilar. Richter’s teriparatide biosimilar Terrosa was launched in Europe in August 2019 [2]. The two companies have been working together since signing a collaboration agreement in 2010 [3].

Teriparatide is a recombinant form of parathyroid hormone used to treat osteoporosis by increasing bone formation. Mochida’s formulation is a 600-microgram subcutaneous injection kit which will allow self-injection. It is the first teriparatide biosimilar to be approved in Japan.

Related articles
Comparison of darbepoetin alfa and epoetin alfa for the treatment of renal anaemia

Two darbepoetin alfa biosimilars submitted to Japan’s PMDA

Biosimilars of teriparatide

Biosimilars of darbepoetin alfa

1. GaBI Online - Generics and Biosimilars Initiative. Japan approves first darbepoetin alfa biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 October 4]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Teriparatide biosimilar Terrosa launched in Europe []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 October 4]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. LG Life Sciences and Mochida make deal for adalimumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 October 4]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: Gedeon Richter, JCR Pharmaceuticals, Mochida

comment icon Comments (0)
Post your comment
Related content
EMA recommends approval of two adalimumab biosimilars
Biosimilars/News Posted 01/10/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010