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Articles tagged with "Food and Drug Administration"

Second Biosimilar Equivalent to Adalimumab

Michele B. Kaufman, PharmD, BCGP  |  November 9, 2016

A recent study established the equivalency of BI 695501, a biosimilar, to its reference product, adalimumab, for treating patients with rheumatoid arthritis…

Many Patients Discontinue Tofacitinib by Year 1; Fasinumab Promising for Pain

Michele B. Kaufman, PharmD, BCGP  |  November 2, 2016

A recent analysis found that about 10% of RA patients taking tofacitinib do not follow recommended guidelines and more than half stop treatment by one year…

Tocilizumab Designated as Breakthrough Therapy for GCA

Michele B. Kaufman, PharmD, BCGP  |  October 26, 2016

To speed the development of tocilizumab to treat giant cell arteritis (GCA), the FDA designated it as a breakthrough therapy earlier this month…

FDA Update: New Boxed Warnings for Opioids & Benzodiazepines; Plus New Drug Safety Labeling Changes Database

Michele B. Kaufman, PharmD, BCGP  |  October 5, 2016

Due to serious side effects from the combined use of opioids and benzodiazepines, the FDA has issued boxed warnings for both types of medication…

Adalimumab-atto, Biosimilar to Humira, Receives FDA Approval

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

Adalimumab-atto, a biosimilar to adalimumab (Humira), has been approved by the FDA to treat multiple autoimmune diseases…

FDA Approves Ustekinumab for Crohn’s Disease

Reuters Staff  |  September 26, 2016

(Reuters)—Johnson & Johnson says on Monday that the U.S. Food and Drug Administration approved the company’s psoriasis drug, ustekinumab (Stelara), for use in adults with Crohn’s disease. The drug is approved in the U.S. to treat plaque psoriasis and a type of arthritis associated with psoriasis. Crohn’s is a chronic inflammatory condition in the gastrointestinal…

FDA Approves Adalimumab-atto, a Biosimilar of Humira

Reuters Staff  |  September 23, 2016

WASHINGTON (Reuters)—The U.S. Food and Drug Administration on Friday approved a cheaper, biosimilar version of AbbVie’s top-selling arthritis drug, adalimumab (Humira). The drug, adalimumab-atto (Amjevita), is made by biotechnology company Amgen Inc. and was approved to treat rheumatoid arthritis, psoriatic arthritis, Crohn’s disease, psoriasis and other conditions. Amjevita is the fourth biosimilar to be approved…

Celltrion Accelerates U.S. Launch of Infliximab-dyyb, a Remicade Biosimilar

Michele B. Kaufman, PharmD, BCGP  |  September 21, 2016

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…

Abaloparatide Promising for Osteoporosis; NICE Draft Guidelines Include Secukinumab for Ankylosing Spondylitis

Michele B. Kaufman, PharmD, BCGP  |  September 14, 2016

In a clinical trial, subcutaneous abaloparatide has proved effective in treating postmenopausal women with osteoporosis. Also in the U.K., draft guidelines for treating ankylosing spondylitis will recommend the use of secukinumab…

FDA Approves Etanercept-szzs Biosimilar

Michele B. Kaufman, PharmD, BCGP  |  September 2, 2016

Although it may not be available until 2017, the FDA approved the use of etanercept-szzs for multiple autoimmune diseases…

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