BC Week In Review | Nov 18, 2016
Company News

Benepali etanercept and Flixabi infliximab biosimilar news

Studies conducted by Biogen comparing biosimilar autoimmune drugs Benepali etanercept (SB4) and Flixabi infliximab (SB2) to Enbrel etanercept and Remicade infliximab, respectively, showed that the two biosimilars could lead to "substantial cost savings" in European...
BC Week In Review | Nov 17, 2016
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,...
BC Week In Review | Sep 26, 2016
Company News

Merck, Sanofi endocrine/metabolic news

Sanofi filed a suit in the U.S. District Court for the District of Delaware alleging that Merck infringed 10 Orange Book-listed patents covering Sanofi’s Lantus insulin glargine and Lantus SoloStar pen. Last month, Merck said...
BC Week In Review | Sep 19, 2016
Clinical News

Brenzys biosimilar etanercept regulatory update

Samsung Bioepis Co. Ltd. and Merck said Canada approved Brenzys etanercept, a biosimilar of autoimmune drug Enbrel etanercept, to treat rheumatoid arthritis (RA) and ankylosing spondylitis (AS). Merck will commercialize the biosimilar in Canada. The...
BC Week In Review | Sep 5, 2016
Company News

Merck sales and marketing update

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) recommended that Merck’s biosimilar Brenzys etanercept “could be marked as equivalent” to reference product Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS). The recommendation would give pharmacists the authority...
BC Week In Review | Aug 8, 2016
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...
BC Week In Review | Jul 25, 2016
Clinical News

Biosimilar adalimumab regulatory update

EMA accepted for review an MAA from Samsung Bioepis Co. Ltd. for SB5, a biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV, Chicago, Ill.). Samsung Bioepis declined to disclose whether the company is seeking SB5’s...
BC Week In Review | Jul 25, 2016
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 receptor (INSR)  ...
BC Week In Review | Jul 25, 2016
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 receptor (INSR)  ...
BC Week In Review | Jun 20, 2016
Clinical News

Biosimilar adalimumab: Additional Phase III data

Data from 508 patients with moderate to severe RA despite methotrexate therapy in a double-blind, European Phase III trial showed that 40 mg subcutaneous SB5 every other week led to an ACR20 response rate at...
Items per page:
1 - 10 of 267
BC Week In Review | Nov 18, 2016
Company News

Benepali etanercept and Flixabi infliximab biosimilar news

Studies conducted by Biogen comparing biosimilar autoimmune drugs Benepali etanercept (SB4) and Flixabi infliximab (SB2) to Enbrel etanercept and Remicade infliximab, respectively, showed that the two biosimilars could lead to "substantial cost savings" in European...
BC Week In Review | Nov 17, 2016
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,...
BC Week In Review | Sep 26, 2016
Company News

Merck, Sanofi endocrine/metabolic news

Sanofi filed a suit in the U.S. District Court for the District of Delaware alleging that Merck infringed 10 Orange Book-listed patents covering Sanofi’s Lantus insulin glargine and Lantus SoloStar pen. Last month, Merck said...
BC Week In Review | Sep 19, 2016
Clinical News

Brenzys biosimilar etanercept regulatory update

Samsung Bioepis Co. Ltd. and Merck said Canada approved Brenzys etanercept, a biosimilar of autoimmune drug Enbrel etanercept, to treat rheumatoid arthritis (RA) and ankylosing spondylitis (AS). Merck will commercialize the biosimilar in Canada. The...
BC Week In Review | Sep 5, 2016
Company News

Merck sales and marketing update

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) recommended that Merck’s biosimilar Brenzys etanercept “could be marked as equivalent” to reference product Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS). The recommendation would give pharmacists the authority...
BC Week In Review | Aug 8, 2016
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...
BC Week In Review | Jul 25, 2016
Clinical News

Biosimilar adalimumab regulatory update

EMA accepted for review an MAA from Samsung Bioepis Co. Ltd. for SB5, a biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV, Chicago, Ill.). Samsung Bioepis declined to disclose whether the company is seeking SB5’s...
BC Week In Review | Jul 25, 2016
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 receptor (INSR)  ...
BC Week In Review | Jul 25, 2016
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 receptor (INSR)  ...
BC Week In Review | Jun 20, 2016
Clinical News

Biosimilar adalimumab: Additional Phase III data

Data from 508 patients with moderate to severe RA despite methotrexate therapy in a double-blind, European Phase III trial showed that 40 mg subcutaneous SB5 every other week led to an ACR20 response rate at...
Items per page:
1 - 10 of 267