Biosimilar
FDA approves Ziextenzo, biosimilar to pegfilgrastim
Written, verbal patient education prior to biosimilar switching recommended for JIA
Rheumatology practices should provide written and verbal patient education, and supply adequate teaching for all staff, prior to nonmedical biosimilar switching for patients with juvenile idiopathic arthritis, according to recommendation published in Pediatric Rheumatology.
FDA approves osteoporosis follow-on biologic
The FDA on Monday approved an osteoporosis medication — PF708 — developed by Pfenex under the 505(b)(2) regulatory pathway as a follow-on biologic to teriparatide injection, according to a press release from the company.
Celltrion obtains positive CHMP opinion for subcutaneous infliximab biosimilar
Celltrion received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for the subcutaneous formulation of its infliximab biosimilar intended to treat rheumatoid arthritis, according to a manufacturer release.
Adalimumab, IBI303 biosimilar demonstrate comparable safety, efficacy in AS
IBI303, a biosimilar to adalimumab developed by Chinese biopharmaceutical company Innovent Biologics, is comparable in safety and efficacy to the originator drug among patients with ankylosing spondylitis, according to data published in The Lancet Rheumatology.
Will more biosimilar agents help lower the high cost of insulin?
Click here to read the Cover Story, "Insulin prices reach tipping point diabetes advocates stakeholders demand new solutions."
Court ruling upholds Enbrel patent claim, blocks biosimilar rivals
A U.S. District Court judge has ruled in favor of Amgen in its lawsuit against Novartis’ Sandoz, which claimed patent infringement on its biologic etanercept by the biosimilar, etanercept-szzs.
ACR cautions against mandated biosimilar switching for AS, axSpA
Adults with active ankylosing spondylitis despite treatment with a first TNF-inhibitor, as well as those with stable disease receiving an originator TNF inhibitor, should not be switched to a biosimilar, according to updated recommendations from the American College of Rheumatology published in Arthritis Care & Research.
Arthritis drug market rattles as upadacitinib wins race to FDA approval
In a landmark FDA approval, AbbVie’s upadacitinib has won the race to enter the drug market as the third JAK inhibitor approved for the treatment of moderate-to-severe rheumatoid arthritis, with the drug expected to be available in the United States within the month.
Association of Women in Rheumatology address obstacles, opportunities for female providers
More than 300 registered attendees are expected in Hilton Head, South Carolina, this week for the sixth annual Association of Women in Rheumatology (AWIR) meeting.