Biologics/DMARDs

New RA Therapy Promising in Clinical Trial

Michele B. Kaufman, PharmD, BCGP | August 3, 2016

Results from a clinical trial support the efficacy of vobarilizumab for treating RA. Plus, the UK will recommend the use of certolizumab pegol to treat severe cases of RA in upcoming guidelines…

Secukinumab Inhibits Structural Joint Damage in Active PsA

Arthritis & Rheumatology | July 27, 2016

Psoriatic arthritis (PsA), a chronic inflammatory arthritis characterized by structural damage to the joints, has been associated with reduced health-related quality of life, disability and reduced life expectancy. The joint changes in PsA are characterized radiographically by a combination of erosive and proliferative bone changes, including erosive joint destruction, fluffy periostitis and pencil-in-cup deformities. Radiographic…

U.S. FDA Panel Backs Valeant Psoriasis Drug with Risk Program

Toni Clarke | July 21, 2016

(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically…

Tildrakizumab Promising for Plaque Psoriasis; FDA Approves Adalimumab to Treat Panuveitis

Michele B. Kaufman, PharmD, BCGP | July 20, 2016

n clinical trials, tildrakizumab was more effective than etanercept and placebo at treating moderate to severe plaque psoriasis. Adalimumab has received approval for treating non-infectious intermediate, posterior and panuveitis—its 10th FDA indication…

Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting

Michele B. Kaufman, PharmD, BCGP | July 15, 2016

In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…

FDA Panel Supports Novartis Biosimilar of Etanercept

Reuters Staff | July 14, 2016

(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…

FDA Panel Backs Amgen Biosimilar of Humira

Toni Clarke | July 13, 2016

(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…

FDA Staff Says Amgen Biosimilar ‘Highly Similar’ to AbbVie’s Humira

Reuters Staff | July 8, 2016

(Reuters)—Amgen Inc’s biosimilar form of AbbVie Inc.’s adalimumab (Humira) arthritis drug, the world’s top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration (FDA). The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers…

Infliximab Biosimilar Cross Reacts to Infliximab Antibodies; Plus Treat-to-Target Strategy Promising for Treating RA with bDMARDs

Michele B. Kaufman, PharmD, BCGP | July 6, 2016

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…

Biosimilars: Unanswered Questions

Susan Bernstein | July 5, 2016

Debate continues about how biosimilars that are emerging to treat rheumatic diseases will be named and monitored, said panelists at a recent meeting in Washington, D.C.—Biosimilars in the United States: Next Steps. Angus Worthing, MD, FACR, FACP, a member of the ACR’s Government Affairs Committee, shared rheumatologists’ concerns as these new therapies come to market….