Practice

Patients With Pemphigus Vulgaris May Benefit From Early Rituximab

October 14th 2018

By The Center for Biosimilars Staff

Pemphigus vulgaris (PV) is a rare immune-mediated skin disorder, typically occurring in middle-aged and older adults, that involves painful blistering of the skin and mucous membranes. While many patients are well controlled on systemic corticosteroid treatment, steroid-sparing therapy can be desirable for treating moderate to severe forms of the disease, and rituximab is one such agent to show promise in this indication.

ODAC Hearing Shows the Mood on Biosimilars Is Changing, Oncologist Says

October 12th 2018

By Kelly Davio

Article

Kashyap Patel, MD, a medical oncologist at Carolina Blood and Cancer Care, said after the FDA’s Oncologic Drug Advisory Committee (ODAC) hearing on CT-P10 that "Clearly, the mood has changed to be a lot more favorable for the biosimilars.”

Biosimilar Nocebo Effect Is a Real Risk That Requires a Serious Strategy, Paper Argues

October 8th 2018

By Kelly Davio

Article

According to the authors, the medical literature points to 3 key triggers of the nocebo effect, all of which offer possible solutions to overcoming the nocebo effect in switches to biosimilars.

Standardized Dose Rounding for Infliximab Reduces Costs, Study Demonstrates

October 8th 2018

By The Center for Biosimilars Staff

Article

Infliximab accounts for substantial drug spending in the United States, and dose rounding has become a common practice at many facilities as a way to avoid wasting vials that have only been partially used. However, many institutions do not have standardized approaches to rounding doses, and because infliximab requires a weight-based dose, rounding becomes even more complex.

Health Canada Approves Trastuzumab for Subcutaneous Administration

October 1st 2018

By Kelly Davio

Article

Health Canada has approved a formulation of Roche’s originator trastuzumab, Herceptin, that is intended for subcutaneous administration. The drug, indicated to treat HER2-positive cancers, can be administered in 2 to 5 minutes (versus an average of 90 minutes for intravenous administration).

Literature Review Finds Insufficient Evidence for Biosimilar Nocebo Effect

October 1st 2018

By The Center for Biosimilars Staff

Article

In explaining why some patients who switch to biosimilars from reference biologics discontinue their therapy at a higher rate than those who remain on a therapy without interruption, some authors have referenced the so-called “nocebo” effect. This effect, whereby a patient experiences disease worsening or adverse events due to negative beliefs about a drug, has been controversial, however, and not all clinicians agree that the effect is to blame for differences in discontinuation.

With Payers Under Pressure, Biosimilars Must Demonstrate Their Value

September 27th 2018

By Kelly Davio

Article

In recent years, payers in Europe have been increasing their scrutiny of new therapies as increasingly high-cost drugs come to the market. And while the United States does not have the same cost constraints as the single-payer health systems, it too faces heightened pressures to lower costs in order to afford innovative therapies.

Switching to Biosimilars in the NHS Provides Savings, Presents Unique Challenges

September 26th 2018

By Kelly Davio

Article

Fraser Cummings, MBChB, DPhil, led one of the first clinical teams to switch patients receiving the reference infliximab (Remicade) to CT-P13 (Remsima) in UK clinical practice. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Cummings explained his experience with this switch in his gastroenterology clinic, and looked ahead to the arrival of adalimumab biosimilars in the National Health Service (NHS).

NHS Releases Patient Education Materials in Preparation for Biosimilar Adalimumab

September 25th 2018

By Samantha DiGrande

Article

The National Health Service’s (NHS) Specialist Pharmacy Service released resources for clinicians to use with patients in the discussions around switching from the reference Humira to a biosimilar.

Switching to Biosimilars in Rheumatological Indications Is Safe, Review Says

September 25th 2018

By Kelly Davio

Article

The latest review seeking to reassure clinicians about the safety of switching their patients to biosimilars focuses on rheumatology indications.