Rheumatology

Study Finds that CT-P13 May Be Effective in Takayasu Arteritis

January 17th 2019

By Samantha DiGrande

Researchers recently sought to evaluate the efficacy and safety of infliximab biosimilar CT-P13 in the treatment of Takayasu arteritis (TAK), a granulomatous inflammatory vasculitis that affects the aorta and can cause aneurysms to form. Some patients with TAK benefit from corticosteroids or second-line, small-molecule immunosuppressive agents, but there is a demand for more effective therapeutic options.

Rituximab Biosimilar Is Safe, Effective, and Cost-Saving in RA, but When Will US Patients Benefit?

January 17th 2019

By Kelly Davio

Article

When Celltrion and Teva’s biosimilar rituximab, CT-P10, earned FDA approval under the brand name Truxima in late 2018, it was authorized only for oncology indications, as the drug’s sponsors did not seek indications in inflammatory diseases because of issues related to patent exclusivity on some indications. However, the biosimilar has shown efficacy in treating rheumatoid arthritis (RA), and a European analysis found that the budget impact of introducing CT-P10 could dramatically reduce the cost to treat severe RA.

Eye on Pharma: Mycenax's Tocilizumab Biosimilar Performs in Phase 1 Trial

January 3rd 2019

By The Center for Biosimilars Staff

Article

Drug maker Mycenax has reported positive phase 1 data for its proposed biosimilar tocilizumab, referencing Actemra.

Amgen Submits BLA for Proposed Infliximab Biosimilar

December 18th 2018

By The Center for Biosimilars Staff

Article

Drug maker Amgen announced this week that it has submitted a Biologics License Application (BLA) for ABP 710, a proposed infliximab biosimilar referencing Remicade.

New Treatment Guideline for PsA Recommends First-Line Anti-TNF Biologics

December 5th 2018

By The Center for Biosimilars Staff

Article

This week, the American College of Rheumatology and the National Psoriasis Foundation released a new treatment guideline for psoriatic arthritis (PsA) that contains evidence-based recommendations on caring for patients with this inflammatory disease.

EMA to Review Celltrion's Subcutaneous Infliximab Biosimilar

December 4th 2018

By The Center for Biosimilars Staff

Article

Celltrion has announced that the European Medicines Agency (EMA) has accepted for review an extension marketing authorization application for a subcutaneous formulation of the company’s biosimilar infliximab, CT-P13 (sold in Europe as Remsima and in the United States as Inflectra).

After Biosimilar Deals, UK Spending on Adalimumab Will Drop by 75%

November 26th 2018

By Kelly Davio

Article

This morning, the United Kingdom’s National Health Service (NHS) announced that it has completed negotiations over using the best-value adalimumab product, and it has arrived at a plan whereby it will save £300 million (approximately $386 million) of its current £400 million-per-year (approximately $514 million) spending on adalimumab.

Anti-TNF Therapy Reduces Glycosaminoglycan Levels in Women With RA

November 22nd 2018

By Kelly Davio

Article

Despite the extensive body of literature on rheumatoid arthritis (RA), the exact causes of the disease are not fully understood. Tumor necrosis factor alpha (TNF) is known to play a key role in the disease by stimulating catabolic processes and causing inflammation, and important elements of inflammation include changes in extracellular matrix compounds and their constituents, such as glycosaminoglycans.

Systematic Review Does Not Find Significant Risk Associated With a Single Switch

November 12th 2018

By Kelly Davio

Article

As more biosimilars make their way to patients in the United States and Europe, stakeholders seek reassurance on switching to these products. A newly published systematic review sought to investigate the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders.

A Timeline of US Biosimilar Adalimumab Launch Dates

November 11th 2018

By The Center for Biosimilars Staff

Article

AbbVie has struck agreements with multiple developers over biosimilar adalimumab, forestalling US market entry until 2023. Here's when each product could potentially reach US patients.