Rheumatology

Biosimilar Candidate PF-06410293 Shows Similarity to Humira at 26 Weeks

August 20th 2018

By Kelly Davio

Pfizer’s PF-06410293, a proposed biosimilar adalimumab referencing Humira, shares similar efficacy, safety, and immunogenicity profiles with its reference at 26 weeks of treatment, new research reports.

Treating RA With Infliximab, Adalimumab, or Golimumab May Allow for Later Biologic-Free Remission

August 16th 2018

By Kelly Davio

Article

In analyzing the association between biologic-free remission maintenance and the type of biologic drugs that patients had used, a notable difference emerged between patients who used infliximab, adalimumab, or golimumab versus those who received etanercept and certolizumab pegol.

Study: Switching to SB5 From Humira Is Safe and Well Tolerated at 1 Year

August 15th 2018

By Kelly Davio

Article

Full 52-week results of the study, which included a switch from the reference adalimumab to SB5, demonstrate that the biosimilar was well tolerated and that switching led to no change in treatment-emergent adverse events.

Patients Treated With Tocilizumab May Be Able to Discontinue Methotrexate

August 11th 2018

By Samantha DiGrande

Article

Combination treatment is typically more effective than treatment with methotrexate alone, but some patients may experience adverse events with methotrexate that make monotherapy desirable.

Celltrion Announces Simultaneous Phase 1, Phase 3 Trials for Adalimumab Biosimilar

August 8th 2018

By The Center for Biosimilars Staff

Article

Korean drug maker Celltrion has announced that it ready to begin phase 1 and phase 3 clinical trials for CT-P17, a proposed adalimumab biosimilar referencing AbbVie’s Humira, which is used to treat a variety inflammatory diseases. The trials will be conducted simultaneously at 75 sites in 8 nations in the European region including the United Kingdom, and the company indicates that the trials will be completed by 2020.

Ixifi Has Similar Efficacy to Remicade in RA, With or Without Dose Escalation

August 6th 2018

By Kelly Davio

Article

Pfizer’s Ixifi, a biosimilar infliximab product that was approved for all indications of its reference in the United States in December 2017, received FDA clearance with a data package that included findings from a phase 3, randomized, double-blind, active-controlled, multinational study comparing the biosimilar with the reference infliximab in combination with methotrexate in patients with rheumatoid arthritis (RA). The data were presented in an abstract at the American College of Rheumatology’s annual meeting in 2017, and the results for the initial 30-week treatment period have now been published in Arthritis Research and Therapy.

Two Trials of Low-Dose Rituximab Have Implications for Biosimilarity Testing

August 1st 2018

By Kelly Davio

Article

The researchers hypothesized that currently used doses of rituximab, of 375 mg/m2 or greater, significantly exceed the half-maximal effective dose of rituximab, at which differences between a biosimilar and the reference would be most likely to be found.

Study: Adalimumab Monotherapy Provides Benefits Up to 3 Years in RA

July 30th 2018

By Kelly Davio

Article

While data are becoming more numerous on the feasibility of withdrawing a biologic from a patient who has reached low disease activity (LDA) on combination therapy, data concerning the ability to maintain a treatment target on biologic monotherapy are fewer. A new, post-hoc study reported that adalimumab, used as monotherapy, led to positive clinical, functional, and radiographic outcomes in patients with RA for up to 3 years in more than half of patients who reached LDA after combination therapy.

On-Demand, Low-Dose Rituximab Proves Effective in Treating RA

July 24th 2018

By Kelly Davio

Article

Rituximab, primarily used as a second-line biologic therapy, was used in a cost-saving and adverse-event reducing on-demand schedule in 94.6% of patients; these patients were assessed for signs of relapse and the need for another rituximab infusion at their regularly scheduled visits, and they also had the option of contacting a healthcare provider by phone if they felt that they were relapsing.

Study Shows No Increase in Healthcare Utilization After a Nonmedical Switch to a Biosimilar

July 23rd 2018

By Kelly Davio

Article

Six months after patients switched from reference infliximab to biosimilar infliximab, there was no meaningful increase in patients’ outpatient healthcare use, according to a new study.