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Biocon’s Insulin Glargine gets approval in Japan

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| TNN | Mar 28, 2016, 02.52 PM IST

http://timesofindia.indiatimes.com/business/india-business/Biocons-Insulin-Glargine-gets-approval-in-Japan/articleshow/51583333.cms

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.

 

Kiran Mazumdar–Shaw


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.

 

 

Biocon Limited
Public company
Traded as BSE532523
NSEBIOCON
Industry Biotechnology
Founded 1978
Founder Kiran Mazumdar-Shaw
Headquarters Bangalore, Karnataka, India
Key people
Kiran Mazumdar-Shaw, (Chairman & MD)
Products Pharmaceuticals
Enzymes
Revenue 22.41 billion (US$330 million) (2014–15)[1]
Increase 3.61 billion (US$54 million) (2014–15)
Number of employees
5,585 (Mar 2011)[1]
Subsidiaries Syngene
Clinigene
Website www.biocon.com

//////Biocon,  Insulin Glargine, approval,  Japan


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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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