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Amgen releases results of Phase III study of infliximab biosimilar, revealing no clinically meaningful differences to Remicade®.

Celltrion launches infliximab biosimilar in Libya and Tunisia. The product will be distributed through Celltrion’s local partner Hikma Pharmaceuticals and is part of Celltrion’s overall plan to expand sales networks across Africa and into the Middle East.

US Senators Chuck Grassley and Amy Klobuchar urge FTC to investigate ‘pay-for delay’ settlements, in particular AbbVie’s Humira settlements, for anti-competitive behaviour.  Of particular concern is investigating whether these settlements are keeping biosi...

Celltrion resubmits application for marketing approval of trastuzumab biosimilar to the FDA. This follows CRLs from the FDA related to the February warning letter regarding Celltrion’s manufacturing facility in South Korea.

Sandoz reports results of long term switching studies for biosimilars Zessly®(infliximab) and Erelzi® (etanercept) in RA.

Biocad announces phase III clinical trials of ASART-2, biosimilar infliximab, reveal non-inferiority to Remicade at week 54.

The National Institute for Health and Care Excellence (NICE) rejects pertuzumab for adjuvant treatment of early breast cancer. The draft guidance reports that the drug may not extend patient’s lives and is not cost effective.

Sandoz reports results of long term switching studies for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in RA.

Fresenius reports the results of its Ph III studies for biosimilar adalimumab MSB11022 in moderate-to-severe chronic plaque psoriasis at the European League Against Rheumatism’s Annual European Congress of Rheumatology.