Three darbepoetin alfa biosimilars approved in Japan

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Three darbepoetin alfa biosimilars approved in Japan

Biosimilares/Novedades | Posted 04/10/2019 0 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.

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.

Two darbepoetin alfa biosimilars submitted to Japan’s PMDA

Biosimilars of teriparatide

Biosimilars of darbepoetin alfa

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

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Source: Gedeon Richter, JCR Pharmaceuticals, Mochida