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Merck Launches Biosimilars Clarified, a New Online Educational Resource about Biosimilar Medicines for Patients and the Healthcare Community
2016-10-14 14:30:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the launch of Biosimilars Clarified (www.merckclarifiesbiosimilars.com), a new educational website for patients, caregivers and the healthcare community that is designed to provide clear, concise and straightforward information about biosimilar medicines. Language: English Contact: MerckRobert Consalvo, 908-236-1127 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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Merck Announces FDA Accepts Samsung Bioepis Biologics License Application (BLA) for SB2 (Infliximab), an Investigational Biosimilar of Remicade
2016-05-24 01:50:08| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. First BLA Filed by Samsung Bioepis as Part of Its Partnership with Merck KENILWORTH, N.J. Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade. Language: English read more
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UPDATE 4-FDA staff backs biosimilar to Remicade; J&J and AbbVie fall
2016-02-06 16:40:24| Food - Topix.net
A man walks past a logo of Celltrion Inc in front of the plant in Incheon, west of Seoul April 26, 2013. U.S. Food and Drug Administration staff members on Friday said Celltrion Inc's biosimilar form of Johnson & Johnson's Remicade arthritis drug appeared "highly similar" to the widely used branded product.
Merck Announces Samsung Bioepis Receives Approval of RENFLEXIS (Infliximab), a Biosimilar of Remicade, in Korea
2015-12-07 14:00:00| Merck.com - Corporate News
Dateline City: KENILWORTH, N.J. Samsung Bioepis Second Immunology Biosimilar Approved, to be Commercialized Under Partnership with Merck KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that Samsung Bioepis Co., Ltd. has received approval of RENFLEXIS (infliximab), a biosimilar of the immunology medicine Remicade, by the Ministry of Food and Drug Safety (MFDS) in Korea. Merck will commercialize Samsung Bioepis RENFLEXIS in Korea as part of Mercks commercialization partnership with Samsung Bioepis to offer high-quality biosimilar alternatives to existing biologic medicines. Language: English Contact: MerckMedia:Pamela Eisele, 267-305-3558orRobert Consalvo, 908-236-1127orInvestors:Teri Loxam, 908-740-1986orAmy Klug, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
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No Rehearing Of Biosimilar Patent Dance Decision
2015-10-21 00:14:28| Biotech - Topix.net
The Federal Circuit denied the petitions for rehearing en banc filed in Amgen Inc. v. Sandoz Inc. , which was the court's first decision interpreting the Biologics Price Competition and Innovation Act .
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