Clinical trials have begun to determine if disodium zoledronate tetrahydrate is safe and effective for treating pain in patients with knee osteoarthritis. The FDA has approved the use of ixekizumab for the treatment of plaque psoriasis. And a study has shown that patients with SLE treated with belimumab may be able to decrease steroid use…
NEW YORK (Reuters Health)—Sifalimumab, an anti-interferon alpha monoclonal antibody, may lead to some improvement in patients with systemic lupus erythematosus (SLE), according to a new trial. In a paper online on March 23 in Annals of the Rheumatic Diseases, Dr. Munther Khamashta of King’s College London and colleagues note that treatment of SLE presents a…
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 On Jan. 16, 2016, EMA granted marketing authorization in the European Union for Benepali to be used to treat rheumatoid arthritis (RA), psoriatic…
NEW YORK (Reuters Health)—Hidradenitis suppurativa can complicate biologic therapy of chronic inflammatory diseases, according to a retrospective study from France and Belgium. Hidradenitis suppurativa (HS) often responds to treatment with biologic agents, but there have been scattered reports of patients developing HS while undergoing biologic therapy. Dr. Coline Faivre from Hôpital Edouard Herriot in Lyon,…
The FDA has received an application to expand the use of etanercept to treat plaque psoriasis in pediatric patients. Boehringer Ingelheim and AbbVie have announced a collaborative partnership to develop treatments for multiple autoimmune diseases. And gerilimzumab may prove safe and effective for treating inflammatory diseases at very low doses…
The FDA has officially approved an infliximab biosimilar for the treatment of multiple autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Prescribing information is now available…
NEW YORK (Reuters Health)—Patients with antibodies to infliximab in Remicade should not be switched to biosimilars, researchers warn. “(The) antibodies will cross-react with the new biosimilar drug, potentially reducing clinical response,” Dr. Daniel Nagore, director of research and development at Progenika Biopharma in Derio, Spain, told Reuters Health by email. “The study highlights the importance…
(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Inflectra, a cheaper version of Johnson & Johnson’s drug Remicade (infliximab), to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine. Inflectra, also known as infliximab-dyyb, is expected by some analysts to sell for a 25% discount to Remicade, which generated annual…
LONDON (Reuters)—Lower-cost copies of complex biotech drugs, known as biosimilars, could save the U.S. and Europe’s five top markets as much as 98 billion euros ($110 billion) by 2020, a new analysis showed on Tuesday. Realizing those savings, however, depends on effective doctor education and healthcare providers adopting smart market access strategies, the report by…