Allison Inserro

Fewer than one-third of patients newly diagnosed with rheumatoid arthritis (RA) used anti–tumor necrosis factors agents, other biologics, Janus kinase inhibitors, or conventional disease-modifying antirheumatic drugs in 2014.

Researchers examining the mandatory switch of patients with rheumatoid arthritis (RA) from the originator etanercept (Enbrel) to the biosimilar etanercept (Benepali) found no changes in overall healthcare utilization or cost of healthcare following the switch.

With rising concern over rising drug prices, policymakers have sought a better understanding of the roles of pharmacy benefit managers (PBMs) in the drug supply chain and plans' and PBMs' efforts to manage Part D drug spending and use.

A recent study of a rapid point-of-care (POC) test shows that it is virtually identical at detecting antidrug antibodies (ADAs) to a biosimilar infliximab, SB2 (Renflexis, Flixabi), as a standard enzyme-linked immunosorbent assay (ELISA) and is suitable for therapeutic drug monitoring of any infliximab product.

A recent article described a quality improvement project at the oncology specialty pharmacy unit within the University of Chicago Medicine.

The study was conducted in patients with moderately to severely active rheumatoid arthritis who previously completed the VOLTAIRE-RA study.

The August issue of JAMA Oncology features a Viewpoint that puts forth a free-market solution to lower high drug costs by changing dosing regimens without hurting efficacy using the approach of interventional pharmacoeconomics (IVPE).

Anti–tumor necrosis factor medicines are one of the costliest drugs for many health systems, and in the United Kingdom, a recent article described how one clinical commissioning group managed the switch of patients on the originator etanercept (Enbrel) to a biosimilar (Benepali) using a fixed-price model.

Will biosimilars improve public health? Policy makers should look to that question as they sort through possible solutions, the authors say.

“We wish biosimilar competition would efficiently lower biologics prices to the socially optimal level of marginal economic cost,” wrote Bach and coauthors. “But, in this case, the ideological preference for competition needs to be put aside for a more effective, efficient, and economically justified approach of regulating biologics as natural monopolies.”

The chairman and the ranking member of the Judiciary Subcommittee on Courts, Intellectual Property and the Internet in the House of Representatives, proposed a bipartisan bill to amend the patent dance in the Biologics Price Competition and Innovation Act (BPCIA) by capping the number of some types of patents that may be claimed by the maker of the reference product.

The Federal Trade Commission (FTC) issued civil subpoenas to Johnson & Johnson (J&J) in June as part of an antitrust investigation into the contracting practices for the autoimmune drug Remicade, the originator infliximab sold by its Janssen unit, the company said in a regulatory filing on Monday.

The FDA Friday issued a black box warning for the 10-mg, twice-daily dose of tofacitinib, sold under the names Xeljanz or Xeljanz XR; the drug is an oral, small-molecule Janus kinase (JAK) inhibitor. In addition, this week researchers released phase 3 study results of an investigational JAK inhibitor, filgotinib; the drug showed a clinical response, but the researchers said additional work is needed to assess long-term efficacy and safety.

Earlier this month, a federal appeals court heard arguments in Texas v Azar. If the judge sides with the Republican point of view that the entire Affordable Care Act (ACA) is unconstitutional and invalidates the landmark law, the Biologics Price Competition and Innovation Act (BPCIA), the pathway for biosimilars included in the ACA, would have to start over from scratch. That shouldn’t be a problem, according to 2 conservative healthcare and pharmaceutical observers interviewed by The Center for Biosimilars®.

A bipartisan bill introduced in the Senate Monday calls for cutting insulin prices up to 75% via a measure aimed at insurers and pharmacy benefit managers (PBMs). The bill, introduced by Senator Jeanne Shaheen, D-New Hampshire, would prohibit PBMs and insurers from receiving rebates for insulin if the drug maker has lowered its 2020 list prices to 2006 levels.

Senator Ted Cruz, R-Texas, has reintroduced a bill he thinks will speed US approval of drugs, biologics, or devices approved in other countries.

The top 3 drugs in 2018 in the United States by spending were adalimumab, insulin glargine, and etanercept, according to a study in The American Journal of Health-System Pharmacy, which also predicted that drug spending will grow 4% to 6% this year.

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.

More than 100 House Democrats this week wrote to US Trade Representative Robert E. Lighthizer to ask him to drop language from the United States-Mexico-Canada Agreement (USMCA) trade agreement that would give 10 years of marketing exclusivity for biologic drugs.

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.

The Center for Biosimilars® had a conversation with Alexandra D. Valenti, JD, of Goodwin’s Intellectual Property Litigation group, to help understand the recent discussions in the Senate Judiciary Committee about ongoing attempts at patent reform.

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.

With trastuzumab biosimilars expected on the US market soon for HER2-positive breast cancer, an advocacy organization for patients with breast cancer said recently that it wants to provide education about the potential of the medicines to lower costs and provide more treatment options.

A study published in The New England Journal of Medicine examining rituximab in membranous nephropathy found that it is noninferior to cyclosporine in inducing proteinuria remission at 12 months and is superior to maintaining long-term remission up to 24 months in patients at high risk for progressive disease.

Two economists from the American Enterprise Institute (AEI) shot back at the idea that biosimilars are natural monopolies and should have their prices regulated by the government, as was proposed a little more than 2 months ago by critics who say that trying to wring lower drug prices through competition born from biosimilars is an experiment doomed to fail.

Industry insiders discuss current trends about the patent dance and other issues, as well as proposed legislation that could affect biosimilar development.

Courts will be busy with biosimilar litigation for the foreseeable future, attorneys predicted at a panel on the second day of the ACI 10th Summit on Biosimilars.

A panel at the ACI 10th Summit on Biosimilars focused on the recent FDA decision around the naming of biosimilar products and what that means for the industry, as well as related issues.

The first set of presentations on day 2 of the ACI 10th Summit on Biosimilars on Tuesday in New York City reviewed the economics of biosimilar drugs and considerations for access, pricing, and reimbursement.

Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.