19:32 , Sep 14, 2018 |  BC Week In Review  |  Clinical News

Celltrion NDA for rituxan biosimilar awaits FDA panel discussion

FDA's Oncologic Drugs Advisory Committee will meet on Oct. 10 to review a resubmitted BLA for CT-P10 from Celltrion Inc. (KRX:068270), the company's biosimilar of Rituxan/MabThera rituximab. Celltrion resubmitted the BLA in May, two months after...
19:59 , Sep 11, 2018 |  BC Extra  |  Company News

FDA panel to discuss Celltrion biosimilar

FDA's Oncologic Drugs Advisory Committee will meet on Oct. 10 to review a resubmitted BLA for CT-P10 from Celltrion Inc. (KRX:068270), the company's biosimilar of Rituxan/MabThera rituximab. Celltrion resubmitted the BLA in May, two months after...
18:04 , Aug 8, 2018 |  BC Extra  |  Company News

Samsung planned $22B investment includes biopharma, AI

Samsung Group (Seoul, South Korea) said it would invest W25 trillion ($22.2 billion) over the next three years in biopharmaceuticals and artificial intelligence, among other sectors. While Samsung did not disclose details of the plans,...
17:51 , Aug 3, 2018 |  BC Week In Review  |  Company News

Celltrion wins another biosimilar infliximab lawsuit

A federal judge ruled July 30 that biosimilar Inflectra infliximab-dyyb from Celltrion Inc. (KOSDAQ:068270) does not infringe a patent from Johnson & Johnson (NYSE:JNJ) covering autoimmune drug Remicade infliximab. The decision follows a previous Celltrion...
22:04 , Aug 1, 2018 |  BC Extra  |  Company News

Celltrion wins another biosimilar infliximab lawsuit

A federal judge ruled Monday that biosimilar Inflectra infliximab-dyyb from Celltrion Inc. (KOSDAQ:068270) does not infringe a patent from Johnson & Johnson (NYSE:JNJ) covering autoimmune drug Remicade infliximab. The decision follows a previous Celltrion victory...
21:26 , Jul 27, 2018 |  BioCentury  |  Regulation

Biosimilar barriers

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars...
21:52 , Jul 12, 2018 |  BC Extra  |  Company News

Korea: Samsung Biologics violated accounting rules

Korea’s Securities and Futures Commission ruled Thursday that Samsung BioLogics Co. Ltd. (KSE:207940) violated accounting rules during its 2016 IPO and has requested dismissal of executives and referral of the case to prosecutors. The move...
18:07 , Jun 29, 2018 |  BC Week In Review  |  Company News

Biogen ups biosimilar JV stake

Biogen Inc. (NASDAQ:BIIB) exercised its option to increase ownership in Samsung Bioepis to about 49.9% from 5.4%. Samsung Bioepis is a biosimilars JV between Biogen and Samsung BioLogics Co. Ltd. (KSE:207940), which will receive $700...
21:43 , Jun 28, 2018 |  BC Extra  |  Company News

Biogen ups biosimilar JV stake

Biogen Inc. (NASDAQ:BIIB) exercised its option to increase ownership in Samsung Bioepis to about 49.9% from 5.4%. Samsung Bioepis is a biosimilars JV between Biogen and Samsung BioLogics Co. Ltd. (KSE:207940), which will receive $700...
19:01 , Jun 1, 2018 |  BC Week In Review  |  Company News

Samsung JV may not be in Biogen's long term plans

Biogen Inc. (NASDAQ:BIIB) management said staying in its Samsung Bioepis JV with Samsung BioLogics Co. Ltd. (KSE:207940) may not be in its long-term plans. The comments about the biosimilars JV formed in 2012 were made...