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You are here: Home / Search for "biosimilar"

Search results for: biosimilar

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

November 17, 2021 • By Michele B. Kaufman, PharmD, BCGP

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. ... [Read More]

Filed Under: Analgesics, Biologics & Biosimilars, Drug Updates Tagged With: adalimumab, adalimumab-adbm, Biosimilars, celecoxib, interchangeability, Pain Management, tramadol

FDA Approves Cyltezo, an Interchangeable Biosimilar to Humira

October 19, 2021 • By U.S. Food & Drug Administration

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… [Read More]

Filed Under: Biologics & Biosimilars, Drug Updates Tagged With: adalimumab, adalimumab-adbm, Biosimilars, Cyltezo, FDA approval, Humira, U.S. Food and Drug Administration (FDA)

Insight into the Biosimilar Prescribing Habits of Rheumatologists

June 23, 2021 • By Michele B. Kaufman, PharmD, BCGP

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.... [Read More]

Filed Under: Biologics & Biosimilars, Drug Updates Tagged With: biosimilar, International, prescription, prescription habits, rheumatologists

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

May 28, 2021 • By Michele B. Kaufman, PharmD, BCGP

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.... [Read More]

Filed Under: Biologics & Biosimilars, Drug Updates Tagged With: Biosimilars, etanercept, injection pen, syringe, YLB113-002

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

May 24, 2021 • By Michele B. Kaufman, PharmD, BCGP

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.... [Read More]

Filed Under: Biologics & Biosimilars, Drug Updates Tagged With: Biosimilars, denosumab, EB1001, monoclonal antibody

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

March 22, 2021 • By Lara C. Pullen, PhD

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.... [Read More]

Filed Under: Biologics & Biosimilars, Drug Updates Tagged With: Biologics & Biosimilars, infliximab, infliximab-abda, non-medical switching, Renflexis (infliximab-abda)

New Clinical Trials for Ustekinumab & Denosumab Biosimilars Begin Recruitment

March 17, 2021 • By Michele B. Kaufman, PharmD, BCGP

Clinical trials of biosimilar treatments, including a phase 1 study of SB17, which is biosimilar to ustekinumab, and two phase 3 studies investigating of SB16, which is biosimilar to denosumab, are currently recruiting.... [Read More]

Filed Under: Biologics & Biosimilars, Drug Updates Tagged With: biosimilar, clinical trials, denosumab, SB16, SB17, ustekinumab

FDA Approves New Rituximab Biosimilar & Anakinra to Treat a Rare Disease

February 2, 2021 • By Michele B. Kaufman, PharmD, BCGP

The FDA has approved anakinra to treat a rare autoinflammatory disease, deficiency of interleukin 1 receptor antagonist. The administration also approved a new rituximab biosimilar, Riabni, for multiple indications.... [Read More]

Filed Under: Biologics & Biosimilars, DMARDs & Immunosuppressives, Drug Updates Tagged With: anakinra, deficiency of interleukin 1 receptor antagonist (DIRA), FDA, FDA approval, Riabni, rituximab-arrx, U.S. Food and Drug Administration (FDA)

Patients Demonstrated Good Medication Adherence While Taking Biosimilar Treatment

December 7, 2020 • By Michele B. Kaufman, PharmD, BCGP

Researchers found half of patients taking the biosimilar infliximab-dyyb (Inflectra) remained highly adherent to medication use after 12 months.... [Read More]

Filed Under: ACR Convergence, Biologics & Biosimilars, Drug Updates, Meeting Reports Tagged With: ACR Convergence 2020, adherence, INFLECTRA (infliximab-dyyb), infliximab-dyyb

UHC Updates Rituximab Policy to Require Use of Biosimilars

October 19, 2020 • By From the College

As of Oct. 1, UnitedHealthcare (UHC) requires that patients fail to respond to both FDA-approved rituximab biosimilars prior to receiving approval for rituximab. Exception: Rituximab-pvvr (Ruxience) is not FDA approved for rheumatoid arthritis.... [Read More]

Filed Under: Billing/Coding Tagged With: biosimilar substitution, non-medical switching, prior authorization, rituximab, rituximab-abbs, UnitedHealthCare (UHC)

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