JCR files for Japanese approval of agalsidase beta biosimilar Posted 06/10/2017

Japan-based JCR Pharmaceuticals (JCR) announced on 29 September 2017 that it had applied for Japanese regulatory approval for its agalsidase beta biosimilar (JR‑051).

The product is a proposed biosimilar version of Genzyme’s Fabry disease treatment Fabrazyme (agalsidase beta). Fabry disease is an inherited disease caused by the lack of an enzyme called alpha-galactosidase A, in the body. The rare disease is characterized by pain in the extremities, clouding of the cornea, renal failure and cardiac dysfunction. Approximately 600 patients in Japan and 10,000 worldwide suffer from the disease, according to JCR.

Alpha-galactosidase is a glycoside hydrolase enzyme that hydrolyses the terminal alpha-galactosyl moieties from glycolipids and glycoproteins. It is encoded by the GLA gene. Two recombinant forms of alpha-galactosidase exist, called agalsidase alpha and agalsidase beta.

JCR is developing the agalsidase beta biosimilar (JR‑051) in collaboration with GlaxoSmithKline for Japan and Asia-Oceania territories. The companies announced positive results for their pharmacokinetics study in February 2015, which they said ‘demonstrated the bioequivalence of JR-051’. In addition, the companies say that ‘the phase II/III clinical trial with Fabry patients initiated in May 2015 generated results that demonstrated equivalence in efficacy and safety of JR-051 compared with the innovator product’.

If approved, JCR says JR‑051 will be the first domestic enzyme replacement therapy (ERT) available to Fabry patients. It will also be the first product to come out of JCR’s lysosomal storage disease pipeline. Other ERT products under development include JR‑141 (blood–brain barrier penetrating therapeutic enzyme for Hunter syndrome) and JR‑162 (J-Brain Cargo-applied therapeutic enzyme for Pompe disease).

JCR already has a biosimilar approved in Japan. Epoetin alfa BS (epoetin alfa biosimilar 1) was approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in January 2010 [1].

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan

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Source: JCR

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