Nippon Kayaku and Celltrion Announce Marketing Approval in Japan for Adalimumab Biosimilar Monoclonal Antibody.
26 Sep 2023
Drug Approval
TOKYO, Japan I September 25, 2023 I Nippon Kayaku Co., Ltd. (Tokyo, Japan, President: Atsuhiro Wakumoto; hereinafter referred to as “Nippon Kayaku”) and Celltrion Healthcare Japan K.K. (Tokyo, Japan, President: Hogun Kim; hereinafter referred to as “Celltrion”) today announced that Nippon Kayaku has been obtained the manufacturing and sales approval of Adalimumab BS Subcutaneous Injection 20mg Syringe 0.2mL・40mg Syringe 0.4mL・80mg Syringe 0.8mL・40mg Pen 0.4mL・80mg Pen 0.8mL “CTNK” (hereinafter referred to as “Adalimumab BS “CTNK”) in Japan.
Adalimumab BS “CTNK” is a biosimilar of the Adalimumab monoclonal antibody that has played an important role in treatment of Rheumatoid Arthritis, Inflammatory Bowel Disease and other autoimmune diseases. Currently approved in 32 countries globally (as of Sep. 2023), including South Korea, EU (European Union) and US.
Nippon Kayaku and Celltrion will make an effort to promote the proper use of this drug, provide information, and ensure a stable supply. In addition, we will promote the domestic development of biosimilars and make an effort to contribute to patients, their families, and medical professionals.
SOURCE: Nippon Kayaku
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