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Articles tagged with "Biosimilars"

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…

Big Pharma vs. Big Pharma in Court Battles over Biosimilar Drugs

John Miller  |  October 4, 2016

ZURICH (Reuters)—The line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines. These drug makers are now increasingly straddling both sides of the courtroom, too, protecting their high-price products from biosimilars—biopharmaceutical drugs with the treatment properties of medicines…

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 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…

Potential Benefits, Pitfalls of Biosimilars Reviewed at EULAR 2016

Thomas R. Collins  |  September 8, 2016

LONDON—The availability of a bio­similar form of infliximab has dramatically increased the number of Norwegians taking one form or another of the drug, an expert on biosimilars said in a debate-style session at the Annual Congress of the European League Against Rheumatism (EULAR 2016). The expanded uptake of Remicade (infliximab) and its biosimilar, Remsima (international…

Possible Impact of Biosimilar Infliximab on U.S. Market in Prescriptions, Pricing

Kimberly Retzlaff  |  September 8, 2016

The use of biosimilars for rheuma­tology in the U.S. became a reality when the U.S. Food and Drug Administration (FDA) approved Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab), in April. What this may mean is increased competition among drug companies with regard to pricing and, therefore, potentially lower costs for U.S. patients, according to Seoyoung…

Understanding Prescription Pathways for Biologic Medication Therapy

Andrew Hochradel, PharmD, & the ARHP Practice Committee  |  September 8, 2016

Executing evidence-based medicine in the U.S. is challenging, especially utilizing high-cost medications in rheumatologic care. As patients trust their clinicians to be their medical experts, clinicians must trust their care team members to be experts at implementing the care plan. A clinician’s knowledge of human anatomy and physiology is the foundation to understanding pathophysiology. From…

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…

U.S. FDA Approves Biosimilar to Etanercept

Reuters Staff  |  August 30, 2016

(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Novartis AG’s biosimilar version of Amgen Inc.’s arthritis drug etanercept (Enbrel). The FDA approved the drug, Erelzi, known also as etanercept-szzs, for multiple inflammatory conditions, including rheumatoid arthritis and plaque psoriasis, a skin condition. The agency approved the drug as a biosimilar, meaning there is no…

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