Neurology

Ten Reasons Why Biosimilar Candidates Should Not Be Tested for Clinical Efficacy

October 31st 2020

By Sarfaraz K. Niazi, PhD

Article

The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials add little value, Sarfaraz K. Niazi, PhD, states.

Europeans Devise Checklist for Promoting Biosimilar Use

October 24th 2020

By Deana Ferreri, PhD

Article

European investigators have derived a set of core principals for developing higher utilization of biosimilars.

Revance Reports Positive Findings for Potential Botox Competitor

October 15th 2020

By Tony Hagen

Article

DaxibotulinumtoxinA met all end points in a study demonstrating longer duration of action, safety, and tolerability.

Commentary Questions Differing Global Standards for MS Biosimilar Approvals

January 27th 2020

By Maggie L. Shaw

Article

A recently published commentary examines the global multiple sclerosis (MS) drug market from the perspective of patients and physicians, noting that different regulatory bodies have different standards in place for approvals, and questions if safety concerns are being addressed.

Low-Dose Rituximab May Be Cost-Effective for Myasthenia Gravis

December 28th 2019

By The Center for Biosimilars Staff

Article

Autoimmune myasthenia gravis is typically treated with surgery, acetylcholine esterase inhibitors, corticosteroids, and immunosuppressive drugs like azathioprine and mycophenolate mofetil. Some patients have refractory disease and may require therapies like eculizumab (Soliris), which, while effective, is a particularly high-cost biologic that has no approved biosimilars in Europe or the United States, although biosimilars are advancing through clinical development. Rituximab, however, which is lower-cost than eculizumab and has multiple approved biosimilars, has also emerged as a promising treatment.

Retrospective Study of 56 Million Patients Shows Reduced Risk of Alzheimer With Anti-TNF Use

December 5th 2019

By Kelly Davio

Article

Researchers from biotech company Tetra Therapeutics have reported that, in their retrospective population-based study of 56 million patients with inflammatory diseases, use of anti–tumor necrosis factor (anti-TNF) agents was linked with a reduced risk of Alzheimer disease.

First Patients Dosed in Phase 3 Study of Natalizumab Biosimilar

November 21st 2019

By The Center for Biosimilars Staff

Article

On Monday, Polpharma Biologics announced that it has randomized the first patients in its phase 3 study of PB006, a proposed natalizumab biosimilar, and patients have begun to receive the study medication.

At ANA 2019, Studies Detail the Role of Eculizumab in MG as Competitive Therapies Advance

October 14th 2019

By The Center for Biosimilars Staff

Article

While eculizumab is being targeted by multiple biosimilar developers who are in phase 3 clinical trials with their competitive products, spending on eculizumab is reaching concerning levels; as such, it is increasingly important to clarify eculizumab’s place in the treatment paradigm for myasthenia gravis (MG).

Studies Report on Efforts to Optimize Rituximab in MS, NMOSD

September 21st 2019

By Kelly Davio

Article

While rituximab does not carry indications for the treatment of multiple sclerosis (MS) or aquaporin-4-positive (AQP4) neuromyelitis optica spectrum disorder (NMOSD), the CD20-depleting therapy and its biosimilars are commonly used off-label, as the therapy has been demonstrated to be effective in reducing relapses in MS as well as in reducing the frequency and severity of attacks in NMOSD.

New Data From PREVENT Show Benefits of Eculizumab in NMOSD

September 13th 2019

By Kelly Davio

Article

During this week’s meeting of the European Committee for Treatment and Research in Multiple Sclerosis, held September 11-13 in Stockholm, Sweden, researchers are presenting new data for eculizumab in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disorder that typically affects the optic nerves and spinal cord and that can cause significant, irreversible disability.