Bio-pharma major Biocon on Monday became the first Indian company to receive regulatory approval for a biosimilar insulin in Japan. This approval will enable the company to export Glargine, a biosimilar insulin in a disposable pen to Japan for treatment of diabetes.
In Japan, Biocon has partnered with FUJIFILM Pharma Co Ltd (FFP) to launch this product. FUJIFILM conducted local clinical trial in Japan. They also paid licensing fee to Biocon for the initial development of Glargine.
“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,” Mazumdar-Shaw said.
The approval from the Ministry of Health, Labour and Welfare (MHLW) of Japan marks Biocon’s entry into regulated market with biosimilars. The market in Japan is estimated at $144 million for insulin Glargine. The global market for the same is estimated at over $10 billion.
The company had unveiled a medical devices manufacturing facility at Bengaluru in September last year as part of its commitment to the Make in India programme. The company had also launched Basalog One, a Glargine disposable pen for Indian market.
Biocon is also preparing to file application for four biosimilars including insulin Glargine in the regulated markets of the US and Europe during the next financial year. Biocon has partnership with US drug major Mylan for these biosimilars in those markets.
Under the terms of the deal with Japanese firm, Biocon will get royalty on sale. will launch its ready-to-use, prefilled disposable pen with 3 ml of 100IU Insulin Glargine.
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 our partner in Japan, Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said.
With this approval Biocon aims to capture a portion of the Japanese Glargine market estimated at $144 million, which is the second largest market outside of North America & Europe and is largely dominated by disposable pens, she said.
Biocon’s manufacturing facilities for Insulin Glargine, and disposable pen assembly facility, were inspected and approved by the Japanese regulatory authorities.
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.