Jackie Syrop

The researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan.

Three quantification assays optimized for therapeutic drug monitoring of Remicade can be used to monitor levels of the infliximab biosimilar Flixabi (sold in the United States as Renflexis).

Rituximab is frequently used off-label as a treatment for relapsing-remitting multiple sclerosis (MS) because it induces the depletion of circulating B-cell and T-cell lymphocytes and targets CD20 protein in B cells that are responsible for the production of antibodies.

Results of a small Greek observational study suggest that biosimilar infliximab may be an effective alternative for the treatment of patients with inflammatory bowel disease (IBD) who have active disease and experienced a loss of response to innovator infliximab (Remicade).

The best predictors of which US counties’ patients are most likely to be prescribed higher-priced drugs are income, healthcare costs, and access to exercise opportunities, according to a new study published online in Nature Communications.

Among long-term responders, first-line bevacizumab-based therapy is more effective in patients with HER2-negative metastatic breast cancer (MBC) who were not previously treated with taxanes, a recent Spanish study suggests.

Rituximab-based immunochemotherapy can be safely applied in patients after obinutuzumab-associated anaphylaxis, but the existing risk of cross­reactivity should be considered, and careful monitoring of such patients during rituximab infusion is required.

Up to 60% of Crohn disease patients taking an anti—tumor necrosis factor (TNF) monoclonal antibody medication eventually stop responding to treatment, but the optimal management of these patients has not been clearly defined.

A new study suggests that CD8+ natural killer cells are a biomarker that can predict therapeutic outcome for patients with ankylosing spondylitis who are administered anti–tumor necrosis factor agents because they are nonresponsive to conventional treatment.

Adherence and persistence rates for biologic drugs are still low in the United States, leading to suboptimal patient outcomes and putting a substantial burden on the healthcare system.

Transitioning from reference adalimumab (Humira) to Amgen’s FDA- and EU-approved adalimumab biosimilar ABP 501 (Amgevita) was not associated with increased immunogenicity over an observation period of 72 weeks in patients with rheumatoid arthritis, according to the results of a study presented at the European Congress of Rheumatology.

Italian researchers report that 72% of their trial participants being treated for psoriatic arthritis achieved sustained remission with ETN 25 mg biweekly, which was maintained a year after treatment initiation.

Despite progress in the successful treatment of patients with rheumatoid arthritis (RA) who are using conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) and biological DMARDs (bDMARDs), a Greek study has found that a considerable number of patients are still not achieving low disease activity (LDA) despite having been treated following established recommendations for RA therapy.

An analysis by consumer website GoodRx concluded that the price people pay for generic drugs at the pharmacy varies greatly based on where they live.

A survey of German patients who used a prefilled pen for subcutaneous delivery of biosimilar etanercept SB4 has reported a very high level of patient satisfaction with the product following an interim analysis.

The new rule imposes a 10% fee-for-service cut on any provider who doesn’t opt into a managed-care network, and rural hospitals are especially concerned about the financial losses the change may cause.

In the short term, nonmedical switching (NMS) of stable patients with a rheumatic condition from originator biologics to biosimilars could have “considerable” short-term costs for a rheumatology medical center, according to a study presented at the annual European Congress of Rheumatology.

A preliminary study among patients with rheumatoid arthritis (RA) in Norway who were switched from originator etanercept to its biosimilar (SB4) for nonmedical reasons found that patients had good tolerance for the switch to the biosimilar, with no impairment in disease measures.

The FDA continues to update its list of off-patent, off-exclusivity drugs without approved generic competitors to meet the organization's broader goals defined under the Drug Competition Action Plan.

Health Canada, Canada’s governmental health agency, announced that there is now an option for all biological and pharmaceutical new drug submissions to request aligned regulatory reviews between Health Canada and health technology assessment (HTA) organizations.

Research presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology concluded that patients’ attitudes and level of satisfaction with switching to a biosimilar for etanercept or infliximab was associated with their level of health literacy, defined as being given sufficient and necessary information concerning their health.

New International League of Associations for Rheumatology (ILAR) recommendations are now available for the treatment of patients with psoriatic arthritis living in resource-poor regions, including Central and South America and Africa.

The study, conducted in 80 patients with rheumatic diseases who elected to switch from treatment with originator etanercept to biosimilar etanercept, found that 80% were willing to switch, and switching did not affect treatment effectiveness during 1 year of follow up.

Researchers have reported the development of CubiCAR architecture, which has the potential to improve the safety of chimeric antigen receptor (CAR) T-cell immunotherapies for a broad range of patients with cancer.

More than two-thirds of patients with rheumatoid arthritis (RA) previously naïve to biologic disease-modifying anti-rheumatic drugs had an inadequate response to their first biologic during 1 year of follow up, according to a recent Taiwanese study.

An Asian study comparing the quality of glycemic control among patients using biosimilar insulin with those using originator insulin found no independent association of biosimilar insulin with differences in indicators of glycemic control—glycated hemoglobin, insulin dosage, or hypoglycemia.

Specific human leukocyte antigen (HLA) alleles are associated with the formation of anti-drug antibodies to adalimumab in patients with rheumatoid arthritis and hidradenitis suppurativa, potentially causing reduced therapeutic response.

Some cervical cancer patients with advanced or recurrent disease suffer from anaphylaxis after taxane- or platinum-based therapy, and there is no standard treatment for progressive disease that develops during or shortly after platinum-based chemotherapy. Doctors and patients have therefore sought the development of a non-taxane, non-platinum regimen for recurrent cervical cancer.

The researchers found that the majority of publications on biosimilars came from high-income countries, led by the United States.

Higher levels of cancer-related financial toxicity are associated with decreased quality of life, poorer treatment adherence, and poorer survival for adult patients with cancer.