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Biosimilar medicines: Dramatic increase in patient access across Europe europeanpharmaceuticalreview
May 26, 2017
Biosimilar medicines have dramatically increased patient access to biological medicines, according to the recently published QuintilesIMS report on ‘The impact of biosimilar competition in Europe’.
US green light for Remicade biosimilar pharmatimes
April 25, 2017
US regulators have approved Renflexis, a biosimilar referencing Johnson & Johnson’s tumour necrosis factor (TNF)...
FDA Approves Renflexis drugs.com
April 24, 2017
FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade
Submission of Application for Marketing Approval of CT-P6 Trastuzumab Biosimilar Monoclonal Antibody firstwordpharma
April 12, 2017
Nippon Kayaku Co., Ltd. have submitted today an application for marketing approval of the "trastuzumab (genetical recombinant) preparation" biosimilar monoclonal antibody...
European Commission Approves AMGEVITA™ (Biosimilar Adalimumab) for the Treatment of Certain Inflamma americanpharmaceuticalreview
March 27, 2017
Amgen has announced that the European Commission (EC) has granted marketing authorization for AMGEVITA™ (biosimilar adalimumab1) in all available indications.
First Humira biosimilar approved in Europe pharmatimes
March 27, 2017
Amgen has won European approval for its first biosimilar, a version of AbbVie’s blockbuster Humira (adalimumab).
Sandoz biosimilar adalimumab study shows equivalent efficacy europeanpharmaceuticalreview
March 15, 2017
Sandoz, a Novartis division, presented data for its proposed biosimilar adalimumab, GP2017. Their Phase 3 confirmatory efficacy, safety and immunogenicity study met its primary endpoint, demonstrating GP2017 has equivalent efficacy to the reference medici
Bracing for the biosimilar wave Nature Reviews Drug Discovery
March 14, 2017
The regulatory uncertainty around biosimilars in the United States is finally lifting, just months after the first biosimilar monoclonal antibody hit the US market.
Roche reaches global settlement, licensing agreements with Mylan on Herceptin biosimilar firstwordpharma
March 14, 2017
Mylan announced Monday that it agreed to the terms of a settlement with Roche and the Swiss drugmaker's Genentech unit in regards to patents for Herceptin (trastuzumab).
Global trade bodies issue guidance on biosimilar switching europeanpharmaceuticalreview
March 10, 2017
The European Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) have issued joint guidance...

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