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Celltrion announces EU’s CHMP recommended expanding the marketing authorisation for its subcut Remsima® (biosimilar infliximab) to include the following additional indications: IBD, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis...

Merck announces the FDA has approved Keytruda® (pembrolizumab) for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Fujifilm Kyowa Kirin Biologics announces manufacturing and marketing approval in Japan for FKB237 (adalimumab biosimilar). This product was developed in partnership with Mylan and has been marketed as Hulio® in 20 countries across Europe.

Outlook India reports Dr Reddy’s is expecting to launch 25 products in the US market in the current financial year and that Dr Reddy’s Ph III trials of a proposed rituximab biosimilar are progressing as planned.

Janssen announces it has discontinued its Ph III LOTUS study of Stelara® (ustekinumab) in Systematic Lupus Erythematosus due to lack of efficacy.

Samsung Bioepis announces the CHMP has adopted a positive opinion for Aybintio® (biosimilar bevacizumab).

AbbVie and Sosei Heptares announce a $409M deal to discover and develop new immunology drugs.  The agreement covers the drug-discovery, development and commercialisation of small-molecule medicines that target autoimmune and inflammatory diseases using the G protein-coupled...

Aptevo Therapeutics announces it will receive quarterly “low single digit” fixed royalty payments from Pfizer (Wyeth) for 7 years from the first launch of Ruxience® (biosimilar rituximab). The original royalty agreement was signed by Trubion Pharmaceuticals whic...

Sandoz launched its ‘Biosimilars Generation’ campaign, aimed to help Canadians better understand the benefits of biosimilars, their safety and efficacy, and the opportunities for cost savings. The campaign includes a new website aimed at supporting and educating...