Providers Exploit Minor Differences Between Innovator Drugs and Biosimilars

November 24, 2020

Skylar Jeremias


Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.

IGBA Launches Global Biosimilars Week

November 16, 2020

Tony Hagen


The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars.

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

October 31, 2020

Sarfaraz K. Niazi, PhD


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 24, 2020

Deana Ferreri, PhD


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

Revance Reports Positive Findings for Potential Botox Competitor

October 15, 2020

Tony Hagen


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 27, 2020

Maggie L. Shaw


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 28, 2019

The Center for Biosimilars Staff


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 5, 2019

Kelly Davio


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 21, 2019

The Center for Biosimilars Staff


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 14, 2019

The Center for Biosimilars Staff


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).