Rheumatology

Stakeholders Stress Need for Reliable Information, Streamlined Evidence Requirements

March 12th 2020

By Tony Hagen

Stakeholder comments at a biosimilars forum staged by the FDA and Federal Trade Commission focused on improving the quality of information being disseminated about biosimilars and the need to make the approval process less burdensome for manufacturers.

Editorial: Biosimilar Suffixes Are Important for Pharmacovigilance, Uptake

March 10th 2020

By Skylar Jeremias

Article

Two regulatory experts said in an editorial that suffixes for biosimilars can support adverse event reporting and build provider and patient confidence in biosimilars.

Editorial Calls for Monitoring of Low-Dose Methotrexate Users for Adverse Events in Light of New RCT Data

February 26th 2020

By Deana Ferreri, PhD

Article

The use of low-dose methotrexate in rheumatoid arthritis dates back more than 30 years, but despite these decades of clinical use, data on adverse effects have come mostly from observational studies rather than randomized controlled trials (RCTs), the authors say.

Appeals Court Rules J&J Must Face Infliximab Antitrust Suit Brought by Walgreens, Kroger

February 26th 2020

By The Center for Biosimilars Staff

Article

Antitrust claims are a product of federal statute, said the Third Circuit Court of Appeals, in reinstating a Walgreens and Kroger antitrust lawsuit against J&J over its branded infliximab, Remicade.

ACR Releases Guideline to Managing Reproductive Health With Comorbid Rheumatic Disease

February 25th 2020

By Allison Inserro

Article

The guidelines, based on clinical evidence, are a pathway to a shared decision-making process between patients and their physicians, said the American College of Rheumatology (ACR).

2019 Saw Mounting Evidence to Support Nonmedical Switching, Review Article Says

February 21st 2020

By Deana Ferreri, PhD

Article

A recent year-in-review article outlines studies published in 2019 about nonmedical switching from originator biologics to biosimilars in rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis.

AbbVie: Next-Generation Skyrizi and Rinvoq Are Showing Traction in Humira Space

February 21st 2020

By Skylar Jeremias

Article

Pharmaceutical giant AbbVie reports strong revenues for next-generation products the company hopes will provide fill-in revenue as Humira (adalimumab) sales decline and more biosimilars to the blockbuster arthritis drug enter the market.

Study Finds Similar Pharmacokinetics, Safety of SB4 in 2 Self-Delivery Methods

February 13th 2020

By Deana Ferreri, PhD

Article

Previous studies demonstrating equivalence of SB4 to etanercept in pharmacokinetics and safety have used pre-filled syringes, but these devices may be difficult for some patients to use if they have reduced hand dexterity due to the challenges of living with rheumatoid arthritis.

Biosimilar Pipeline Congested by Patent Litigation Bottleneck

February 11th 2020

By Tony Hagen

Article

The orphan drug market could see hefty biosimilar competition, based on revenue potential, and patent struggles need to be resolved before some biosimilars can come to market, according to a speaker reviewing the 2020 pipeline at the Specialty Therapies and Biosimilars Congress.

What Are the Factors for Starting Anti-TNF Inhibitor Biosimilars in RA and AS?

February 11th 2020

By Deana Ferreri, PhD

Article

The study aimed to provide insight into the real-world patterns of biosimilar initiation in patients with rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in Korea by identifying patient characteristics and other factors associated with starting biosimilars using a logistic regression model.