Practice

A paper by Matti Aapro, MD, recently published in Supportive Cancer Care, outlined, for the first time, consensus recommendations on using pegfilgrastim in particular patients and therapeutic scenarios.

New data from an extension period of a phase 3 study of Samsung Bioepis’ SB2 (Renflexis) in patients with moderate to severe rheumatoid arthritis found that there was no clinically meaningful difference in safety, efficacy, or immunogenicity in patients who were switched from reference infliximab to the biosimilar compared with patients who continued treatment with either the reference or the biosimilar without switching.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of October 16.

A Dutch study reports that 24% of patients who switched from originator infliximab to CT-P13, an infliximab biosimilar, discontinued the biosimilar by their 6-month follow-up, mainly for reasons researchers termed “subjective” health complaints.

Rituximab, which is approved for the treatment of some cancers and inflammatory conditions, also holds significant promise for patients with neurological diseases.

While no one argues that orphan drugs that treat rare diseases can be expensive, the drugs’ reputation for being budget-busters is not borne out by a data presented in a recent report by Quintiles IMS Institute.

Switching patients from originator biologics to biosimilars is associated with the potential for a “nocebo” effect, a phenomenon that occurs when a patient’s negative expectation causes a treatment to have a more negative effect than it otherwise would—essentially, the opposite of the placebo effect.

Anti–tumor necrosis factor drugs are expensive, and there are a limited number of choices for IBD treatment, highlighting the need to use every existing agent optimally.

A newly published study found that the prevalence of T helper (Th) lymphocytes, specifically Th9 cells, is higher in patients who have rheumatoid arthritis, and that these cells may also be involved in immune responses against reference infliximab.

Drug manufacturer JCR announced last month that it has submitted a marketing approval in Japan for JR-051, a proposed agalsidase beta biosimilar referenced on Fabrazyme.

In recent paper published in Rheumatology, authors Till Uhlig, MD, and Guro L. Goll, PhD explore some of the remaining barriers to the adoption of biosimilar therapies in Europe. Physician attitudes, patient concerns, and prescribing restrictions on biologic therapies are all identified in the paper as having a role curbing uptake of biosimilars.

The FDA has issued a Complete Response Letter for Mylan and Biocon’s pegfilgrastim biosimilar, MYL-1401H, referenced on Neulasta.

A study newly published in Archives of Disease in Childhood sought to develop much-needed data specific to the treatment of pediatric inflammatory bowel disease with biosimilar infliximab, with a focus on safety and effectiveness.

An international panel of healthcare stakeholders recently released consensus recommendations for the use of biosimilars to treat rheumatologic diseases. Learn more about what the panel had to say.

A phase 3 study comparing Samsung Bioepis’ etanercept biosimilar, SB4, to its reference found that SB4 had comparable efficacy—including radiographic progression—to week 52 of treatment in patients with rheumatoid arthritis.

The number of people who had annual prescription medication costs of $50,000 or more in 2016 was 35% higher than it was in 2014, according to pharmacy benefit manager Express Scripts.

While tumor necrosis factor (TNF) deficiency is associated with a higher incidence of tuberculosis, excessive production of TNF is associated with an exaggerated inflammatory response that can result in mycobacterial immune reconstitution inflammatory syndrome (IRIS).

The standard way to conduct mobilization in hematopoietic stem cell donors relies on using 2 original granulocyte-colony stimulating factors (G-CSFs), filgrastim (Neupogen) and lenograstim (Granocyte).

A large Canadian study of patients with inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, reports that a high overall rate of adherence to subcutaneous anti-TNFs.

In real-world community oncology settings, bevacizumab-containing regimens were associated with longer progression-free survival and overall survival compared with non-bevacizumab regimens.

In recent years, a wrench has been thrown into the patient care equation.

In an effort to provide a guide for clinicians and a framework for future educational efforts, an international panel of healthcare stakeholders convened to arrive at consensus recommendations for the use of biosimilars to treat rheumatological diseases.

The FDA has approved Mvasi, the first biosimilar bevacizumab (Avastin).

According to a new study, potential savings realized from transitioning to treatment with biosimilar filgrastim-sndz from reference filgrastim are not only significant, but these savings can also be applied to expand access to novel immunotherapies or supportive care.

How can the US healthcare system learn from the European Union on market penetration for biosimilar products?

Three posters presented on September 10, 2017, at the European Society for Medical Oncology (ESMO) 2017 meeting in Madrid, Spain, covered research on 2 proposed pegfilgrastim biosimilars and evaluated the use of filgrastim in oncology practice.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 4, 2017.

Biologic agents represent the highest single cost associated with rheumatoid arthritis (RA) infusion care, a new analysis finds, with personnel, supplies, and overhead costs contributing substantially to overall costs.

The FDA’s Adverse Event Reporting System, which allows healthcare professionals, patients, and others to submit reports on adverse events, contains over 8.5 million entries, a massive number complicated by the fact that any drug may be listed under an average of 16 different names.

Seth D. Ginsberg, co-founder of Global Healthy Living Foundation, told The Center for Biosimilars®, “Currently the benefit of rebating and pricing of all infused drugs goes to the payers, health systems, hospitals and physicians, not the patients. Until patients participate in such savings, infused drug pricing has nothing to do with them.”