Rheumatology

In Third and Fourth Line in RA, Tofacitinib Monotherapy Proves Similar in Efficacy to Anti-TNFs Plus Methotrexate

November 27th 2019

By The Center for Biosimilars Staff

A recent study assessed tofacitinib versus anti–tumor necrosis factor (anti-TNF) agents using data from the Corrona registry, a large, prospective, observational database of patients with rheumatoid arthritis (RA) in more than 174 practices in 41 US states.

Mandated Switching to Biosimilars Begins in British Columbia, May Spread to Other Provinces

November 27th 2019

By The Center for Biosimilars Staff

Article

The issue of whether to switch patients currently taking biologics to biosimilars has been playing out in Canada over the past week, as mandated switching begins in British Columbia, while a reference product maker fights against a possible similar change in 2 other provinces.

Subcutaneous Formulation of Celltrion's Biosimilar Infliximab Authorized by European Commission

November 26th 2019

By Kelly Davio

Article

Celltrion Healthcare announced that the European Commission has authorized Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis. The product is the first subcutaneous infliximab option to be approved in any regulatory territory.

Nordic Study Shows Similar Retention Rates for Biosimilar and Reference Etanercept, Infliximab

November 25th 2019

By Kelly Davio

Article

Nordic countries have had some of the highest rates of biosimilar use, and extensive registry data in these countries also allow for observational studies of biosimilar use in real-world clinical practice. A new study used data from 5 such registries—which included more than 2000 patients with spondyloarthritis—to assess retention rates for those treated with biosimilars or reference products of etanercept and infliximab.

Long-Term KOBIO Registry Data Show Comparable Drug Retention for Biosimilar CT-P13, Reference Infliximab

November 20th 2019

By Kelly Davio

Article

Biosimilar infliximab CT-P13 (Inflectra, Remsima) has been the subject of numerous studies since its authorization in multiple regulatory territories, and this month, data from the Korean College of Rheumatology Biologics (KOBIO) registry add to the growing body of knowledge about this biosimilar’s use in patients with rheumatoid arthritis in routine clinical practice.

More Data Needed on Using Biologics in Children, Review Says

November 18th 2019

By Allison Inserro

Article

A recent review explored the evidence of monoclonal antibodies (mAb) and fusion proteins (FP) to examine their safety and efficacy in the most common chronic inflammatory diseases in children—bronchial asthma, psoriasis, juvenile idiopathic arthritis (JIA), and chronic inflammatory bowel diseases (IBD).

FDA Approves Pfizer's Adalimumab Biosimilar, Abrilada

November 16th 2019

By Kelly Davio

Article

The FDA has approved Pfizer’s adalimumab biosimilar, Abrilada (adalimumab-afzb), referencing Humira.

Studies Report on Switching, Tolerability, and Infection Risk With Biosimilar Infliximab

November 14th 2019

By Kelly Davio

Article

As the only anti–tumor necrosis factor therapies currently available to US patients with inflammatory diseases, biosimilars of infliximab are increasingly used to treat diseases like rheumatoid arthritis. While there are a wealth of data on real-world use of these products in territories like the European Union, less research has examined their use in the United States. During the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, researchers reported on the results of 3 studies that assessed real-world use of biosimilar infliximab in the US context.

Biologics Show Similar Efficacy in Older Patients as in Younger, No Matter When RA Begins

November 14th 2019

By Allison Inserro

Article

The lead author said the results indicate that biologics can be used in older patients with rheumatoid arthritis (RA) as effectively as in those who are younger.

Newly Presented Data on SB4 Show Successful Switches, Safe Use, and No Evidence of Nocebo

November 13th 2019

By Kelly Davio

Article

While US patients continue to wait for a biosimilar etanercept to become commercially available, real-world data continue to amass for Samsung Bioepis’ biosimilar, SB4, in European clinical practice. The biosimilar, sold as Benepali in the European context, was the subject of several studies presented this week at the American College of Rheumatology’s 2019 meeting, held in Atlanta, Georgia.