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Avik Das | TNN | Mar 28, 2016, 02.52 PM IST
BENGALURU: Biopharmaceutical company Biocon said it got approval from Japan’s health ministry to sell its biosimilar Insulin Glargine in the country.
The product, which is a ready-to-use, prefilled disposable pen with 3 ml of 100IU Insulin Glargine, is expected to be launched in Japan in the first quarter of 2017 with its commercial partner FUJIFILM Pharma Co. Ltd, Biocon said on Monday.
The move will help Biocon capture a significant share of the Japanese Glargine market, which is about $144 million and second largest market outside of North America & Europe.
“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,” chairperson and managing director Kiran Mazumdar-Shaw said.
Biosimilars are biologic products, made inside living cells and has no clinical differences in terms of safety and effectiveness from the main product. They are however not considered duplicates, like generics, by regulators as it is impossible to manufacture exact copies of biotech drugs.
|Traded as||BSE: 532523
|Headquarters||Bangalore, Karnataka, India|
|Kiran Mazumdar-Shaw, (Chairman & MD)|
|Revenue||₹22.41 billion (US$330 million) (2014–15)|
|₹3.61 billion (US$54 million) (2014–15)|
Number of employees
|5,585 (Mar 2011)|
//////Biocon, Insulin Glargine, approval, Japan
Lupin launches insulin glargine in India:
Indian pharma company, Lupin Limited announced a strategic distribution agreement with LG Life Sciences of South Korea to launch Insulin Glargine, a novel insulin analogue under the brand name Basugine™.
According to the agreement, Lupin would be responsible for marketing and sales of Basugine™ in India.
Sanofi’s investigational diabetes drug U300, cas no 160337-95-1, insuline glargine, new formulation is better at controlling dangerous low blood sugar events at night than its blockbuster Lantus, according to data from a phase III clinical programme.
Lantus, developed in the 1990s, is currently Sanofi’s top-selling product, generating $6.6bn last year. But the drug is expected to lose its patent in 2015.
http://www.medscape.com/viewarticle/805067 says no cancer risk
http://clinicaltrials.gov/ct2/show/NCT01689142 reports clinical trials
To compare the efficacy of a new formulation of insulin glargine and Lantus in terms of change of HbA1c from baseline to endpoint (scheduled at month 6 [week 26]) in patients with type 2 diabetes mellitus.
- To compare a new formulation of insulin glargine and Lantus in terms of change in fasting plasma glucose, pre-injection plasma glucose, 8-point self-measured plasma glucose profile.
- To compare a new formulation of insulin glargine and Lantus in terms of occurrence of hypoglycemia
Insulin glargine is produced by recombinant DNA technology using a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. It is an analogue of human insulin made by replacing the asparagine residue at position A21 of the A-chain with glycine and adding two arginines to the C-terminus (positions B31 and 32) of the B-chain. The resulting protein is soluble at pH 4 and forms microprecipitates at physiological pH 7.4. Small amounts of insulin glargine are slowly released from microprecipitates giving the drug a long duration of action (up to 24 hours) and no pronounced peak concentration.