Rheumatology

Using Value-Based RA Pathway Leads to a Shift to Biosimilars for AHG

July 17th 2019

By The Center for Biosimilars Staff

A variety of policy proposals have been put forward to help spur the US uptake of biosimilars, from legislative solutions to regulatory changes, but some providers are taking the matter into their own hands with concerted efforts to bring biosimilars to the clinic.

In a Single-Center Study, Patients With AS Remained in Remission After a Switch to CT-P13

July 14th 2019

By The Center for Biosimilars Staff

Article

As more health systems seek to make use of the cost savings associated with biosimilars, data continue to accrue to support switching patients to these products. One recent paper, published in The Journal of Clinical Medicine, reported that, after a switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), patients with ankylosing spondylitis (AS) who switched to the biosimilar remained in remission at 18 months post-switch.

Mylan Launches Biosimilar Adalimumab, Hulio, in Spain

July 13th 2019

By The Center for Biosimilars Staff

Article

This week, Mylan launched its biosimilar adalimumab, Hulio, in Spain. The biosimilar, referencing Humira, was developed by Mylan’s partner, Fujifilm Kyowa Kirin Biologics, and received European authorization in September 2018.

Samsung Bioepis Gains EU Label Update for Biosimilar Adalimumab, Imraldi

July 8th 2019

By Kelly Davio

Article

Biosimilar developer Samsung Bioepis has gained an updated label for its biosimilar adalimumab, Imraldi, referencing Humira. The biosimilar is now approved for storage in nonrefrigerated conditions for up to 28 days. This update means that the biosimilar can now be stored for an additional 2 weeks at room temperature.

In Treating RA Pain, Could JAK Agents Beat Adalimumab?

July 6th 2019

By The Center for Biosimilars Staff

Article

A recently published study used data from the RA-BEAM trial to assess what proportion of treated patients achieve pain relief and in what time frame, and found that an oral small-molecule Janus kinase (JAK) inhibitor may have some advantages over adalimumab (Humira) when it comes to reducing rheumatoid arthritis (RA) pain.

Eye on Pharma: Bio-Thera's Adalimumab Biosimilar Meets Primary End Point in Phase 3 Study

July 4th 2019

By The Center for Biosimilars Staff

Article

The multicenter, randomized, noninferiority, double-blind, controlled trial was conducted in China among 554 patients with active ankylosing spondylitis.

As Biosimilar Adalimumab Gains Ground in Europe, Ixekizumab Shows Superiority to Humira in PsA

July 2nd 2019

By Kelly Davio

Article

Given the head-to-head data from the SPIRIT trial, Humira maker AbbVie may face even further challenges in trying to maintain its sales as newer products like ixekizumab advance in such therapeutic areas as psoriatic arthritis (PsA).

Switching to Biosimilar Rituximab, Truxima, Is Effective and Well Tolerated in Patients With RA

June 25th 2019

By Kelly Davio

Article

Recently, researchers reported 72-week results from a phase 3 trial of biosimilar rituximab, CT-P10 (Truxima), in patients with rheumatoid arthritis (RA), in which they concluded that the product was well tolerated in long-term use and that switching from the reference did not yield differences in safety, efficacy, pharmacodynamics, or immunogenicity.

Celltrion Presents More Data Showing Comparable Efficacy, Safety of Subcutaneous CT-P13 to IV Form

June 19th 2019

By Allison Inserro

Article

Korean drug maker Celltrion Healthcare recently presented new findings from a 2-part study at the European League Against Rheumatism European Congress of Rheumatology 2019 meeting about subcutaneous biosimilar CT-P13 (Inflectra, Remsima).

Switching Among Multiple Infliximab Biosimilars Does Not Cause Immunogenicity, Study Finds

June 17th 2019

By Kelly Davio

Article

A new study has found that switching among multiple biosimilar infliximab products was not associated with increased immunogenicity in patients with inflammatory diseases.