Practice

Data continue to accrue on the use of biosimilar infliximab, CT-P13 (Inflectra, Remsima), in a variety of disease states, and a recent study among patients with ankylosing spondylitis (AS) who were treated with the biosimilar demonstrated infrequent discontinuation of therapy.

A patient-level simulation model using real-world data from Finland evaluated the cost-effectiveness of abatacept, tocilizumab, and anti–tumor necrosis factor (anti-TNF) therapies as compared with rituximab in patients with rheumatoid arthritis (RA) who received previous treatment with an anti-TNF agent.

The Center for Biosimilars® recaps the top stories for the week of July 15, 2019.

Patients with inflammatory diseases in the United States continue to wait for the availability of a biosimilar etanercept, despite the 2016 approval of Erelzi and the 2019 approval of Eticovo. However, in the European context, biosimilar etanercept is already available, and recently presented data demonstrate that, in some countries, use of the biosimilar is high and making an impact on healthcare costs.

The retrospective, observational, multicenter study included 141 patients, 96 with ulcerative colitis and 45 with Crohn disease, at 14 centers in Italy.

A hospital for rheumatological diseases in the United Kingdom is participating in an international study that is examining real-world evidence about patient experiences after they switch from reference adalimumab (Humira) to a biosimilar, Imraldi.

A variety of policy proposals have been put forward to help spur the US uptake of biosimilars, from legislative solutions to regulatory changes, but some providers are taking the matter into their own hands with concerted efforts to bring biosimilars to the clinic.

Access to biologic drugs is uneven, even in nations with relatively robust healthcare resources. In lower-resource areas, such as Eastern Europe, access to biologic therapy for diseases like inflammatory bowel disease (IBD) may be very limited.

As more health systems seek to make use of the cost savings associated with biosimilars, data continue to accrue to support switching patients to these products. One recent paper, published in The Journal of Clinical Medicine, reported that, after a switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), patients with ankylosing spondylitis (AS) who switched to the biosimilar remained in remission at 18 months post-switch.

A secondary post hoc analysis of patients who had neovascular age-related macular degeneration (AMD) and were treated with intravitreal aflibercept or ranibizumab—2 widely used anti-vascular endothelial growth factor (anti-VEGF) therapies—found that those with certain characteristics had a substantial risk of conversion to AMD in the untreated eye.

This week, a research letter appearing JAMA Internal Medicine reported on efforts to understand whether there exists an association between payments from drug makers and Medicare spending on adalimumab and certolizumab.

The experience of one hospital in the United Kingdom of switching patients to a rituximab biosimilar was described in a recent conference abstract, with the process of switching not going as well as it had previously for patients using infliximab and etanercept.

A recently published study used data from the RA-BEAM trial to assess what proportion of treated patients achieve pain relief and in what time frame, and found that an oral small-molecule Janus kinase (JAK) inhibitor may have some advantages over adalimumab (Humira) when it comes to reducing rheumatoid arthritis (RA) pain.

The subcutaneously administered trastuzumab contains the same monoclonal antibody as the intravenous formulation at a dose of 600 mg per 5-mL vial, plus a recombinant human hyaluronidase, to be used every 3 weeks. The hyaluronidase is used to increase the permeability of the extracellular matrix, allowing for administration of higher volumes and enhanced absorption of the drug.

Under the approach used by Kaiser Permanente, say the authors, in which oncologists have salaried incomes and are not reimbursed on a relationship to drug price, far higher generic uptake has been observed.

As more centers begin to switch patients from reference infliximab to biosimilar options, patients who have benefitted from rapid infusions of the reference product may want to continue to receive time-saving infusions that reduce the burden of lengthy visits to infusion centers.

Starting in 2017, the Henry Ford Cancer Institute started using follow-on filgrastim (tbo-filgrastim, a product approved prior to the establishment of the biosimilar approval pathway in the United States) and biosimilar filgrastim (Zarxio) in stem cell mobilization prior to transplant.

The European Specialist Nurses Organisation has launched 7 new translations of its guide to the management of switches between reference biologics and biosimilars.

June 2019 was a busy month for oncology biosimilars, in both the supportive care and anticancer contexts, with regulatory activity and the presentation of reassuring new data.

No statistically significant risk in terms of lack of effectiveness or safety was found for patients who switched therapies versus those who remained on their first therapy in either the reference group or the biosimilar group.

During the 24th European Hematology Association (EHA) Congress, researchers from the European branch of the Severe Chronic Neutropenia International Registry reported on experience with reference granulocyte colony-stimulating factor products and a biosimilar.

The introduction of infliximab for the treatment of inflammatory bowel diseases (IBD) did not result in lower population rates of hospitalizations or intestinal surgeries among patients living with IBD in Ontario, Canada, according to a study published Thursday.

A new consensus paper from the Asia-Pacific Working Group on inflammatory bowel disease (IBD) released a set of best practices for improving IBD care with biologics and biosimilars.

A consensus statement developed by the Pan American League of Associations for Rheumatology (PANLAR) regarding biosimilars warned against the use of so-called "biomimics," or copy biologics.

“This systematic literature review found that the overall economic impact of biosimilar [nonmedical switching] remains uncertain,” write the investigators. More real-world studies will be necessary, they indicate, to quantify the full economic impact of nonmedical switches over the short and long term.

Early treatment with a biosimilar agent increased total costs by £70 (US $89) per patient versus standard intervention.

With patents on reference products that treat multiple sclerosis (MS) set to expire soon in the region, a panel of experts in Latin America recently published a set of recommendations regarding the efficacy, safety, and quality of biosimilars in these countries.

“Our results suggest that in patients with a contraindication to immunotherapy, such as connective tissue, rheumatologic, or interstitial lung disease, bevacizumab may be a reasonable alternative, instead of pembrolizumab, to add to carboplatin-pemetrexed,” said lead author, Stephen J. Bagley, MD, MSCE, assistant professor of hematology-oncology at Abramson Cancer Center, in a statement.

Infliximab and its biosimilars are often used as a treatment for ulcerative colitis (UC), and recent years have seen the collection of real-world data on the use of biosimilar CT-P13 (Inflectra, Remsima) that confirm the product’s equivalent efficacy to that of the reference, Remicade. One newly published study, which assessed patient data from a French nationwide health administrative database, found that not only is biosimilar CT-P13 as effective as the reference product in treating UC, it may also have a lower risk of serious infections.

In its May 2019 network bulletin, UnitedHealthcare announced that, as of July 1, it will prefer the use of brand-name pegfilgrastim, Amgen’s Neulasta, over biosimilar options.