Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment

Table 4

PMDA approved biosimilars in Japan.

Product name	Therapeutic area	Authorization date	Manufacturer/company name
Somatropin BS	Growth hormone deficiency; Turner syndrome	Jun. 22, 2009	Sandoz
Epoetin alfa BS	Anemia/renal anemia	Jan. 20, 2010	JCR Pharmaceuticals
Filgrastim BS 1	Cancer/neutropenia/hematopoietic stem cell transplantation	Nov. 21, 2012	Fuji Pharma Co.,  Mochida Pharmaceutical
Filgrastim BS 2	Cancer/neutropenia/hematopoietic stem cell transplantation	Feb. 28, 2013	Teva Pharma Japan, Nippon Kayaku Co.
Filgrastim BS 3	Cancer/neutropenia/hematopoietic stem cell transplantation	Mar. 24, 2014	Sandoz Österreich
Infliximab BS	Crohn’s disease/rheumatoid arthritis/ulcerative colitis	Jul. 4, 2014	Nippon Kayaku Co.
Insulin glargine BS	Growth hormone deficiency/Turner syndrome	Jan. 19, 2015	Elli Lily/Boehringer Ingelheim

Source: Generics and Biosimilars Initiative, 2016 [17].