 "Biocon receives regulatory approval for insulin glargine in Japan")
The Ministry of Health, Labour and Welfare (MHLW) of Japan has approved Biocon’s biosimilar insulin glargine. “This is a significant achievement for Biocon and its commercial partner, Fujifilm Pharma Co Ltd (FFP) as it endorses our endeavour to bring high quality, yet affordable, world class products to diabetes patients in Japan,” said Biocon in a press release.
The product is a ready?to?use, prefilled disposable pen with 3 ml of 100 IU insulin glargine, expected to be launched in Q1 FY17, aiming to capture a significant share of the Japanese glargine market of $ 144 million, which is the second largest market outside of North America & Europe and is largely dominated by disposable pens.
The approval for insulin glargine has been obtained post successful completion of initial development by Biocon and local phase III clinical studies in over 250 type 1 diabetes patients by Biocon’s partner in Japan. Biocon’s manufacturing facilities for insulin glargine, and its disposable pen assembly facility, were inspected and approved by the Japanese regulatory authorities. This pen assembly facility was inaugurated in September 2015 for the launch of Biocon’s insulin glargine pen branded as ‘Basalog One’ in India.
The per capita spending on pharmaceuticals in Japan is the second highest among OECD countries after the US, and the government is striving to rationalise healthcare spends by encouraging the entry of high quality yet affordable follow-on biologics. This approval will enable Biocon to address the growing needs of diabetes patients in Japan which reported 7.2 million cases in 2015.
Biocon is recognised as Asia’s largest insulins producer and has been committed to affordable diabetes management through rh?Insulin (Insugen) and Insulin Glargine (Basalog) in India and several emerging markets. The company currently has marketing approvals in over 60 countries for rh?Insulin and in over 20 countries for Insulin Glargine. It is also developing Insulin Glargine for the developed markets outside of Japan in collaboration with Mylan.
The product is a ready?to?use, prefilled disposable pen with 3 ml of 100 IU insulin glargine, expected to be launched in Q1 FY17, aiming to capture a significant share of the Japanese glargine market of $ 144 million, which is the second largest market outside of North America & Europe and is largely dominated by disposable pens.
The approval for insulin glargine has been obtained post successful completion of initial development by Biocon and local phase III clinical studies in over 250 type 1 diabetes patients by Biocon’s partner in Japan. Biocon’s manufacturing facilities for insulin glargine, and its disposable pen assembly facility, were inspected and approved by the Japanese regulatory authorities. This pen assembly facility was inaugurated in September 2015 for the launch of Biocon’s insulin glargine pen branded as ‘Basalog One’ in India.
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Kiran Mazumdar-Shaw, chairperson & managing director, Biocon, said: “The insulin glargine approval in the highly regulated market like Japan, marks a huge credibility milestone for Biocon. We see this as a significant achievement in our journey of making global impact in diabetes management through our affordable biosimilar insulins. We hope to enable the Japanese government to bring down its healthcare expenditure on diabetes with the use of this cost effective, high quality biosimilar insulin glargine.”
The per capita spending on pharmaceuticals in Japan is the second highest among OECD countries after the US, and the government is striving to rationalise healthcare spends by encouraging the entry of high quality yet affordable follow-on biologics. This approval will enable Biocon to address the growing needs of diabetes patients in Japan which reported 7.2 million cases in 2015.
Biocon is recognised as Asia’s largest insulins producer and has been committed to affordable diabetes management through rh?Insulin (Insugen) and Insulin Glargine (Basalog) in India and several emerging markets. The company currently has marketing approvals in over 60 countries for rh?Insulin and in over 20 countries for Insulin Glargine. It is also developing Insulin Glargine for the developed markets outside of Japan in collaboration with Mylan.