Researchers found half of patients taking the biosimilar infliximab-dyyb (Inflectra) remained highly adherent to medication use after 12 months.
U.S. Insurers Often Limit Biosimilar Coverage
(Reuters Health)—U.S. commercial health plans only covered biosimilar treatments as preferred products in 14% of coverage decisions last year, according to an analysis of publicly available data on coverage decisions.1 Researchers examined records from the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database, which has information on coverage decisions made by 17 of…
Biosimilars: How Do They Affect Patient Care & Safety?
CHICAGO—“We have got to get over this hump. We have got to try new stuff,” said Jacqueline M. Fritz, RN, MSN, CNS, to the audience gathered on the final day of the 2018 ACR/ARHP Annual Meeting, referring to the subject of biosimilars. Ms. Fritz, the owner and coordinator of education at the Medical Advancement Center…
FDA Releases Biosimilar Guidance, Medicare Will Cover Infliximab-dyyb & More
The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…
Celltrion Accelerates U.S. Launch of Infliximab-dyyb, a Remicade Biosimilar
After winning the initial patent infringement lawsuit filed by Janssen, Celltrion Inc. is now shipping Inflectra (infliximab-dyyb), a biosimilar of Remicade (infliximab), to the U.S…
Infliximab Biosimilar Cross Reacts to Infliximab Antibodies; Plus Treat-to-Target Strategy Promising for Treating RA with bDMARDs
In a recent study, 100% of patients with rheumatoid arthritis (RA) on infliximab experienced a cross-reaction when switched to its biosimilar (CT-P13, infliximab-dyyb). Plus in a recent study, a treat-to-target strategy proved effective for treating RA with biological disease-modifying anti-rheumatic drugs…
Samsung Bioepis Receives Final European Approval for Its Remicade Copy
SEOUL (Reuters)—South Korea’s Samsung Bioepis said on Monday its biosimilar of Johnson & Johnson’s blockbuster rheumatoid arthritis drug Remicade (infliximab) has received final approval from European regulators, paving the way for its second product launch in Europe. Samsung Bioepis, an unlisted arm of South Korea’s top conglomerate Samsung Group, also said last week the biosimilar…
Mucosal Healing Seen with Infliximab Biosimilar CT-P13 in Ulcerative Colitis
NEW YORK (Reuters Health)—About two-thirds of patients with ulcerative colitis (UC) had mucosal healing by the end of induction treatment with the infliximab biosimilar CT-P13, according to results of the first prospective study to evaluate this. CT-P13 is the first biosimilar monoclonal antibody of reference infliximab (Remicade) approved in Europe and several other countries where…
Infliximab Biosimilar Receives FDA Approval
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…
Remicade Antibodies Cross-React to Biosimilars
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…