Search results for: biosimilar

FDA Grants Interchangeable Designation to Pfizer’s Abrilada, Biosimilar to AbbVie’s Humira

Keri Losavio | October 5, 2023

On Oct. 5, Pfizer announced that Abrilada (adalimumab-afzb), its biosimilar to Humira (adalimumab), had received an interchangeable designation from the U.S. Food & Drug Administration (FDA).

Marching to the Biosimilar Beat: Questions on Rollout Remain

Ruth Jessen Hickman, MD | September 7, 2023

The availability of biosimilars for the treatment of patients with rheumatic diseases exploded in 2023. Here’s where we stand and what to expect going forward.

First Biosimilar to Adalimumab (Humira) Enters the U.S. Market After Years of Legal Battles

Michele B. Kaufman, PharmD, BCGP | January 31, 2023

After years of legal disputes between drug makers, adalimumab-atto (Amjevita) biosimilar to adalimumab (Humira) is now available in the U.S. to treat rheumatoid arthritis and other diseases. Adalimumab-atto is the first of several biosimilars to adalimumab expected to become available in the U.S. in 2023.

FDA Approves Riabni, a Rituxumab Biosimilar, to Treat Patients with RA

Michele B. Kaufman, PharmD, BCGP | July 13, 2022

Based on findings from a double-blind, placebo-controlled study evaluating its efficacy and safety, rituximab-arrx has received FDA approval for the treatment of patients with rheumatoid arthritis.

FDA Approves First Interchangeable Biosimilar to Adalimumab, Plus a Combination Drug Approved

Michele B. Kaufman, PharmD, BCGP | November 17, 2021

Cyltezo (adalimumab-adbm) may be interchanged for Humira (adalimumab) for all indications, according to an October decison by the FDA. The FDA has also approved a new combination of celecoxib and tramadol for pain management.

FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira

U.S. Food & Drug Administration | October 19, 2021

On Oct. 15, the U.S. Food & Drug Administration (FDA) approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to and interchangeable with (i.e, may be substituted for) its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar…

Insight into the Biosimilar Prescribing Habits of Rheumatologists

Michele B. Kaufman, PharmD, BCGP | June 23, 2021

The use of biosimilar treatments is increasing, according to surveys conducted in 2018 and 2020 of rheumatologists from eight countries. In the two-year period, Japan had the largest increase in biosimilar prescriptions, with only 6% of surveyed rheumatologists reporting they prefer prescribing originator biologic agents.

Injection Pen May Reduce Injection Fear Among RA Patients Taking Etanercept Biosimilar

Michele B. Kaufman, PharmD, BCGP | May 28, 2021

Fear of injection decreased when patients with RA switched from self-administering a treatment biosimilar to etanercept in a prefilled syringe to an injector pen, according to a small observational study.

The Race Is On: Clinical Trials Begin for Agents Biosimilar to Denosumab

Michele B. Kaufman, PharmD, BCGP | May 24, 2021

As the U.S. and other patents for branded denosumab products get closer to expiring, drug manufacturers are initiating clinical trials for more affordable, biosimilar versions of the treatment.

When Switching Patients to Biosimilars, Communication & Expert Nurses Reduce the Nocebo Effect

Lara C. Pullen, PhD | March 22, 2021

In a recent study, researchers designed an intervention centered on communication and led by nurses to address discontinuation rates among patients who had switched to a biosimilar. The nurses’ insight and experience reduced the nocebo effect during the intervention, which had an 84% retention rate for patients taking a biosimilar after one year.