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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...
Sandoz proposed biosimilar adalimumab demonstrates equivalent efficacy as Humira cphi-online
March 08, 2017
Comprehensive development program show potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis.
First ever biosimilar of interferon beta-1a approved in Russia cphi-online
March 07, 2017
Represents Biocad's third authorized medicine for the treatment of relapsing-remitting multiple sclerosis.
U.S. FDA accepts biologics license application for Mylan and Biocon’s proposed biosimilar pegfilgras pharmaasia
March 06, 2017
U.S. Food and Drug Administration has accepted Mylan's Biologics License Application (BLA) for MYL-1401H for filing through the 351(k) pathway.
First biosimilar mAb in oncology granted EU approval europeanpharmaceuticalreview
February 24, 2017
The European Commission has approved Truxima (biosimilar rituximab) for all indications of reference rituximab in the European Union.
Pfizer’s Remicade biosimilar displays similar efficacy pharmafile
February 23, 2017
Pfizer and Celltrion have announced new data for their Remicade biosimilar, Inflectra, that shows that the drug is comparable in safety and efficacy, in a recent Phase 3 trial treating Crohn’s disease. Remicade was worth sales of $5.76 billion to Johnson
Celltrion Healthcare’s biosimilar shows positive results in Crohn’s disease study europeanpharmaceuticalreview
February 21, 2017
Celltrion Healthcare presented the primary outcome from its pivotal randomised controlled trial of CT-P13 (biosimilar of infliximab) in Crohn’s disease.
FDA to review Mylan and Biocon’s biosimilar application europeanpharmaceuticalreview
February 20, 2017
The US Food and Drug Administration (FDA) has accepted Mylan and Biocon‘s biologics license application for MYL-1401H, a proposed biosimilar to Neulasta (pegfilgrastim).
FDA accepts BLA for Mylan and Biocon's proposed biosimilar pegfilgrastim for review cphi-online
February 20, 2017
The proposed biosimilar to Neulasta is used to reduce the duration of neutropenia and the incidence of fever associated with neutropenia in adult patients treated with chemotherapy in certain types of cancer.
Generic and Biosimilar Manufacturers launch new brand and campaign cphi-online
February 17, 2017
Generic Pharmaceutical Association becomes Association for Accessible Medicines.

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