Practice

Switching Anti-TNF Agents May Help Patients With Ankylosing Spondylitis

March 8th 2018

By Samantha DiGrande

Anti–tumor necrosis factor (anti-TNF) treatment has revolutionized the management of ankylosing spondylitis (AS), but 20% to 30% of patients discontinue treatment due to failure or inadequate response to treatment. That being said, anti-TNF therapies are structurally different and have different mechanisms of action; consequently, unsuccessful treatment with 1 anti-TNF drug does not determine a patient’s potential response to another.

We Do Not Need to Reinvent the Wheel on Biosimilar Safety, Says Avalere's Gillian Woollett

March 7th 2018

By Kelly Davio

Gillian Woollett, MA, DPhil, senior vice president of Avalere and leader of the company’s FDA practice, told The Center for Biosimilars® in an interview that a study she co-authored is aimed at reassuring all biosimilar stakeholders that, “even though no clinical differences are expected when patients are switched from a reference product to a biosimilar, indeed none are found. Hence, we confirm the expectation already established through the application of sound regulatory science.”

Anti-TNF Therapy Holds Promise for Patients With Coexisting Lupus and RA

March 7th 2018

By Samantha DiGrande

A recent study analyzed the long-term efficacy and safety profile of anti–tumor necrosis factor (anti-TNF) treatment in 15 patients with rhupus, a rare association defined by the coexistence of both systemic lupus erythematosus and rheumatoid arthritis (RA) in the same patient.

Low-Dose Filgrastim Provides Cost Savings and Noninferior Clinical Outcomes for Some Patients

March 6th 2018

By Kelly Davio

To determine whether a course of 300 ug of filgrastim, administered daily for 2 days, achieves the same clinical outcomes that have been reported with the recommended dosage, and whether such a dose could provide cost savings, investigators from Marshall University performed a retrospective chart review to identify all patients at their institution with chemotherapy-induced neutropenia who were treated with 2 consecutive doses of 300 ug of filgrastim between September 2011 and September 2016.

Systematic Literature Review Shows Low Risk of Safety Concerns or Loss of Efficacy After Switching to a Biosimilar

March 5th 2018

By Kelly Davio

In an effort to evaluate whether switching from a reference biologic to a biosimilar could lead to altered clinical outcomes—such as enhanced immunogenicity, compromised safety, or reduced efficacy—a research team, led by Hillel Cohen, PhD, conducted a systematic literature review of all available switching studies.

Phase 1 Clinical Trial of Dornase Alfa Biosimilar to Begin March 2018

March 5th 2018

By The Center for Biosimilars Staff

The proposed biosimilar references Genentech’s Pulmozyme, a biologic first approved in the early 1990s in both the European Union and the United States. Pulmozyme is used in conjunction with other therapies to improve pulmonary function in patients with cystic fibrosis.

The Top 5 Biosimilars Articles for the Week of February 26

March 2nd 2018

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 26, 2018.

Biosimilar Gastroenterology Roundup: February

February 28th 2018

By The Center for Biosimilars Staff

February 2018 saw a number of developments for biosimilars that treat inflammatory bowel disease, with new studies from around the globe adding to the body of data on these therapies.

Biosimilars of Hemophilia Therapies: Are They Likely?

February 28th 2018

By Samantha DiGrande

In a recently published editorial in The Official Journal of the World Federation of Hemophilia, author Angela Thomas, MB, PhD, discusses the advancements in hemophilia treatment as well as the place biosimilars may or may not have in reducing the cost of care.

ACR's 2018 Health Policy Statements Address Biologics, Biosimilars, and the High Cost of Drugs

February 27th 2018

By The Center for Biosimilars Staff

The American College of Rheumatology (ACR) has updated its health policy statements for 2018, and biosimilars featured heavily in the organization’s concerns for the year ahead.