16:50 , Jun 8, 2018 |  BC Week In Review  |  Clinical News

Mylan, Biocon get CRL for insulin glargine follow-on

Mylan N.V. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said they recently received a complete response letter from FDA for their follow-on of diabetes drug Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY). The partners said...
23:08 , Jun 5, 2018 |  BC Extra  |  Company News

Mylan, Biocon get CRL for insulin glargine follow-on

Mylan N.V. (NASDAQ:MYL) and partner Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said they recently received a complete response letter from FDA for their follow-on of diabetes drug Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY). The partners said...
17:16 , Mar 30, 2018 |  BC Week In Review  |  Clinical News

Mylan, Biocon insulin glargine biosimiliar approved in EU and Australia

Mylan N.V. (NASDAQ:MYL) said the European Commission and Australia's Therapeutic Goods Administration each approved Semglee, a biosimilar of diabetes drug Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY). Mylan co-developed Semglee with Biocon Ltd. (NSE:BIOCON; BSE:BIOCON)....
18:22 , Nov 18, 2016 |  BC Week In Review  |  Clinical News

Biosimilar insulin glargine regulatory update

EMA accepted for review an MAA from Mylan for biosimilar insulin glargine to treat Type I and II diabetes. Mylan and Biocon said the MAA includes data showing bioequivalence to Lantus insulin glargine from Sanofi...
14:33 , Nov 17, 2016 |  BC Week In Review  |  Clinical News

Lusduna regulatory update

EMA's CHMP recommended approval of Lusduna from Merck to treat diabetes in patients ages ≥2. The product is a biosimilar of Lantus insulin glargine, a synthetic sustained-release subcutaneous insulin analog from Sanofi (Euronext:SAN; NYSE:SNY, Paris,...
00:13 , Nov 4, 2016 |  BC Extra  |  Company News

EMA reviewing Lantus biosimilar

Mylan N.V. (NASDAQ:MYL) and Biocon Ltd. (NSE:BIOCON; BSE:BIOCON) said EMA accepted for review an MAA for the partners’ biosimilar insulin glargine to treat Type I and Type II diabetes. The companies said the MAA includes...
07:00 , Aug 8, 2016 |  BC Week In Review  |  Clinical News

Biosimilar insulin glargine regulatory update

Merck is partnered with Samsung Bioepis Co. Ltd., a JV between Biogen and Samsung Biologics, to develop and commercialize multiple biosimilars, including MK-1293 (see BioCentury, Feb. 17, 2014). Samsung Biologics is a JV between Samsung...
07:00 , Jul 25, 2016 |  BC Week In Review  |  Clinical News

Biosimilar insulin glargine: Phase III data

Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass.   Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J.   Samsung Group , Seoul, South Korea   Product: Biosimilar insulin glargine ( MK-1293 )   Business: Endocrine/Metabolic   Molecular target: Insulin...
07:00 , Jul 25, 2016 |  BC Week In Review  |  Clinical News

Biosimilar insulin glargine: Phase III data

Biogen Inc. (NASDAQ:BIIB), Cambridge, Mass.   Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J.   Samsung Group , Seoul, South Korea   Product: Biosimilar insulin glargine ( MK-1293 )   Business: Endocrine/Metabolic   Molecular target: Insulin...
07:00 , Apr 4, 2016 |  BC Week In Review  |  Clinical News

Basalog biosimilar insulin glargine regulatory update

Japan approved Biocon’s Basalog, a biosimilar of diabetes drug Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY, Paris, France). Biocon expects to launch the product this quarter. Biocon and Fujifilm partnered to commercialize the biosimilar in...