Samsung Bioepis' Biologics License Application for SB2 Infliximab ...

Merck Announces FDA Accepts Samsung Bioepis' Biologics License ...

for SB2 (infliximab), an investigational biosimilar candidate of Remicade. This BLA is the first application filed in the United States by ...

The US Food and Drug Administration (FDA) has accepted for review the company's Biologics License Application (BLA) for SB2, a biosimilar candidate referencing ...

FDA accepts biologics license application for review from Samsung ...

Samsung Bioepis Co. Ltd. announced the FDA has accepted for review the company's biologics license application for SB2, a biosimilar candidate referencing ...

761054Orig1s000 - accessdata.fda.gov

is currently held by Janssen Biotech, Inc. US-licensed Remicade is the reference product for. Samsung's 351(k) BLA.

Safety, immunogenicity and efficacy after switching from reference ...

SB2 (Samsung Bioepis, Incheon, Republic of Korea) and reference infliximab ... Samsung Bioepis' Biologics License Application for SB2 infliximabb ...

Merck Announces BLA Application for Biosimilar of Remicade (US)

Merck & Co. Inc. announced that the FDA accepted Samsung Bioepis Co., Ltd.'s biologics license application for SB2 (infliximab), a biosimilar candidate ...

News Releases - SAMSUNG BIOEPIS

For more information, please visit:www.samsungbioepis.com ... Prev Samsung Bioepis' Biologics License Application for SB2 Infliximab Biosimilar Accepted by FDA ...

Biologics License Application Accepted for Remicade Biosimilar

... Samsung Bioepis,” said Dora Bibila, general manager of Merck Biosimilars. “If approved, SB2 would offer an important therapeutic option to ...

News Releases - SAMSUNG BIOEPIS

For more information, please visit:www.samsungbioepis ... Next Samsung Bioepis' Biologics License Application for SB2 Infliximab Biosimilar ...

Samsung Bioepis infliximab biosimilar accepted for review by FDA

... Biologics License Application (BLA) submitted by Samsung Bioepis for the companies' infliximab biosimilar candidate, SB2. Rheumatology.org ...

FDA Approves Fifth Biosimilar – Samsung Bioepis's Renflexis ...

Samsung Bioepis announced that the FDA had accepted its biologics license application for SB2, its infliximab biosimilar, in May 2016. The company has ...

Medical Officer's Review of BLA 761054 Division of ... - FDA

... BLA for the proposed drug product RENFLEXIS (SB2) ... Samsung Bioepis is developing SB2 as a proposed biosimilar to US-licensed Remicade.

Samsung Bioepis Submits Marketing Authorization Application For ...

PRNewswire/ -- Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for SB2, its Remicade ...

News Releases - SAMSUNG BIOEPIS

today announced that the European Medicines Agency (EMA) has accepted for review the company's Marketing Authorization Application ... SB2 (infliximab) ...

Samsung Bioepis SB4 And SB2 Investigational Biosimilar ...

Samsung Bioepis' Biologics License Application For SB2 Infliximab Biosimilar Accepted By FDA. Samsung Bioepis Co., Ltd. recently announced ...

FDA Accepts Samsung Bioepis's BLA for Remicade® Biosimilar

Samsung Bioepis Co., Ltd., announced that the FDA has accepted its first biosimilar application submitted in the United States.

Safety and Effectiveness of SB2 (Infliximab Biosimilar) in Adult ...

SB2 (Samsung Bioepis, Incheon, Republic of Korea) is a biosimilar of ... Upon request, and subject to certain criteria, conditions, and exceptions ...

Merck Announces Samsung Bioepis Receives Approval of ...

SB2 Remicade (infliximab) [worldwide ex-EU/Russia/Turkey]; SB4 Enbrel ... Samsung Bioepis is a joint venture between Samsung Biologics and Biogen.

Samsung Bioepis announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for SB2 ...

Samsung Bioepis' Biologics License Application for SB2 Infliximab ...

Samsung Bioepis' BLA for SB2 was based on Phase 1 and Phase 3 clinical studies that tested the biosimilarity of SB2 to Remicade®. In a 54-week ...