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Biologics/DMARDs

Etanercept Biosimilar Approved in EU, Plus FDA Reviews Brodalumab for Plaque Psoriasis

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

An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…

Tocilizumab Plus Methotrexate Faster Fix in Some with RA

David Douglas  |  February 1, 2016

NEW YORK (Reuters Health)—In rheumatoid arthritis (RA) patients with an inadequate response to methotrexate, adding tocilizumab to the regimen is more effective than simply switching to tocilizumab, according to Japanese researchers. Dr. Tsutomu Takeuchi told Reuters Health by email that the approach “more rapidly suppressed inflammation than tocilizumab switched from methotrexate, leading to superior clinical…

3 Clinical Trials Examine Sirukumab for RA; Plus TNF-α Combination & Monotherapies Are Compared for Treating PsA

Michele B. Kaufman, PharmD, BCGP  |  January 27, 2016

Three clinical trials are evaluating subcutaneous sirukumab for safety and efficacy in treating rheumatoid arthritis. And a study found no significant difference in persistence and remission for TNF-α monotherapy when compared with TNF-α plus conventional DMARD combination therapy for treating psoriatic arthritis…

Secukinumab Receives 2 New Approvals: PsA & AS

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

The FDA approved secukinumab (Cosentyx) this past week for the treatment of adults with active ankylosing spondylitis and active psoriatic arthritis. These two new approvals are based on the safety and efficacy outcomes from four placebo-controlled Phase 3 trials in more than 1,500 adults with AS or PsA…

Sarilumab Is Effective for RA, Pregabalin Fails to Meet Study Endpoint & Ibuprofen Can Be Administered with a Patch

Michele B. Kaufman, PharmD, BCGP  |  January 13, 2016

Sarilumab is proving effective for treating RA. In a clinical trial, pregabalin did not meet its endpoint for treating post-traumatic peripheral neuropathic pain. And a 12-hour ibuprofen patch is in development…

Biosimilars Seek Regulatory Approval in the U.S. & Europe; Plus MTX Underused in the U.S.

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

In Europe, an etanercept biosimilar is getting closer to being approved to treat RA and more, and in the U.S., an application for an adalimumab biosimilar has been submitted for FDA approval. Also, an analysis of methotrexate use in the U.S. shows that therapy may actually be underused for RA…

Biologic DMARDs Prove Effective for Psoriatic Arthritis & Combination DMARDs Show Promise for RA

Michele B. Kaufman, PharmD, BCGP  |  December 25, 2015

In clinical trials, ixekizumab and adalimumab proved safe and effective in treating adults with active psoriatic arthritis. Also, the combination therapy of certolizumab pegol plus methotrexate was more effective than placebo for treating severe RA…

New SLE Drug May Allow Patients to Reduce Steroid Use

Michele B. Kaufman, PharmD, BCGP  |  December 16, 2015

In a recent study, the use of anifrolumab in SLE patients was shown to be safe and effective, enabling some patients to decrease their oral steroids. Also, secukinumab has been approved in Europe to treat ankylosing spondylitis and psoriatic arthritis…

Etanercept Biosimilars Promising in Clinical Studies

Michele B. Kaufman, PharmD, BCGP  |  December 2, 2015

In multiple clinical studies, investigational biosimilars for etanercept were shown to be safe and effective for treating rheumatoid arthritis and moderate to severe plaque psoriasis…

Amgen Files for U.S. Approval of Biosimilar

Bill Berkrot  |  November 29, 2015

(Reuters)—Amgen Inc. on Wednesday said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie’s Humira (adalimumab), the world’s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira in late stage clinical trials…

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