Kelly Davio

France has experimented with financial incentives to reward the prescribing of biosimilars. These incentive structures include shared savings for centers that acquire medicines at lower costs, as well as biosimilar prescribing targets.

During the International Society for Pharmacoeconomics and Outcomes Research 2019 meeting being held in Copenhagen, Denmark, 3 teams of researchers presented findings that show that, despite the fact that Europe’s biosimilars market is far more mature than that of the United States, the region still sees setbacks from stakeholder perceptions of biosimilars and from policies that do not adequately incentivize biosimilar use.

The FDA has approved Ziextenzo (pegfilgrastim-bmez), Sandoz’s biosimilar pegfilgrastim referencing Neulasta. The biosimilar was approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive anticancer treatment. Sandoz plans to launch the product this year.

UnitedHealthcare has revised its community and commercial plans’ coverage of erythropoiesis-stimulating agents. Effective January 1, 2020, patients who are receiving the reference epoetin alfa, Epogen or Procrit, will be required to switch to Pfizer’s biosimilar, Retacrit.

The International Society for Pharmacoeconomics and Outcomes Research is holding its Europe 2019 meeting this week in Copenhagen, Denmark, and the savings that biosimilars can afford European healthcare systems are a hot topic at this year’s event. Two studies presented on Monday explored how Amgen’s biosimilar bevacizumab (Mvasi) and biosimilar trastuzumab (Kanjinti) could produce significant cost savings for hospitals in the Italian healthcare system.

The ONWARD study included patients who initiated therapy with the biosimilar, those who switched from the reference infliximab, or those who switched from a different biologic therapy.

This week, during the Academy of Managed Care Pharmacy Nexus 2019 meeting, held in National Harbor, Maryland, healthcare practitioners have gathered to share insights into patient care. Among the groups presenting new findings are 2 research teams that have investigated patterns of use for biosimilar and follow-on products in the United States, and their findings provide insight into how biosimilars are progressing in the US market.

With new research presented this month, and with new biosimilars in the pipeline that target inflammatory bowel disease (IBD), October was a notable month for biosimilars in the gastroenterology space.

The American Society of Clinical Oncology (ASCO) today released its third annual National Cancer Opinion Survey, results of which highlight the added stress that the financial burden of treatment places on patients with cancer.

Biosimilars are beginning to gain momentum, even in the sluggish US market, evidenced by strong US and global sales reported this month by some of the top biosimilar players.

Albert Bourla, DVM, PhD, Pfizer’s chief executive officer, announced during the company’s third quarter 2019 earnings call that Pfizer has set launch dates for its biosimilar rituximab, Ruxience (referencing Rituxan), and trastuzumab, Trazimera (referencing Herceptin).

This week, clinicians gathered in San Antonio, Texas, for the American College of Gastroenterology (ACG)’s 2019 meeting, where a number of presentations focused on the treatment of inflammatory bowel disease. During the congress, 2 studies presented addressed adverse events (AEs) associated with—one of which was resolved by—the use of biosimilar infliximab, CT-P13 (Inflectra).

Drug maker Revance Therapeutics has announced positive results from its SAKURA clinical program for its daxibotulinumtoxinA, a novel botulinum toxin type A that it hopes will compete with brand-name Botox, or onabotulinumtoxinA.

Researchers reported on 1-year follow-up among patients at 2 centers, all of whom had psoriasis or psoriatic arthritis, after Brazilian health authorities issued a 2017 mandate that patients being treated with the reference infliximab be switched to CT-P13, and that new starts be given the biosimilar instead of the reference.

When it comes to considering using biosimilars, savings for patients are providers’ top concern, followed by savings to the healthcare system at large. Yet physicians also rate their own confidence levels in biosimilars as a main hurdle for widespread biosimilar adoption.

The Canadian Association of Gastroenterology and Crohn’s and Colitis Canada this week announced a joint statement on biosimilars in the treatment of inflammatory bowel disease (IBD). The paper, which is slated to appear in the Journal of the Canadian Association of Gastroenterology, recommends that patients stable on biologic treatment should not be subject to nonmedical switching, and recommends against automatic substitution of biosimilars for their references.

A new research report from Milliman, commissioned by the Leukemia and Lymphoma Society (LLS), found that fewer than half of patients with blood cancer received treatment within 3 months of diagnosis, and LLS says that costs may be keeping patients from getting care.

Writing in a viewpoint in JAMA, Walid F. Gellad, MD, MPH, and Chester B. Good, MD, MPH, both of the University of Pittsburgh, argue that the deep cost savings achieved in Europe for biosimilar adalimumab are unavailable to the United States because of settlements struck between AbbVie and the developers of all FDA-approved biosimilars.

While providers are increasingly comfortable with switching patients with inflammatory bowel disease (IBD) from reference biologics to biosimilars on the basis of a wealth of reassuring data on the safety and efficacy of such transitions, there are fewer data available about switching among multiple biosimilars of the same reference.

Therapeutic drug monitoring is of particular importance in optimizing treatment for patients with inflammatory bowel disease (IBD) who are receiving therapy with anti–tumor necrosis (anti-TNF) drugs like adalimumab. This week, during the United European Gastroenterology (UEG) Week 2019 meeting, held in Barcelona, Spain, researchers will present new findings on monitoring serum trough levels of Samsung Bioepis’ biosimilar adalimumab, Imraldi, in patients with IBD.

In December 2018, biosimilar developer Amgen announced that it had submitted its proposed infliximab biosimilar, ABP 710, referencing Remicade, to the FDA for review. A regulatory decision is expected shortly, and last week, researchers published detailed results from the biosimilar’s phase 1 clinical study that evaluated the pharmacokinetic (PK) similarity of the biosimilar with its reference.

On Friday, Humana filed a lawsuit in the Eastern District of Pennsylvania, alleging that 37 defendants engaged in a “far-reaching conspiracy” to “blatantly fix the price” of generic drugs.

During the United European Gastroenterology Week 2019 meeting, held in Barcelona, Spain, researchers presented results of a phase 1 pivotal study of a subcutaneously administered formulation of biosimilar infliximab, CT-P13 (Remsima, Inflectra), in patients with inflammatory bowel disease (IBD).

Yesterday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Mundipharma’s pegfilgrastim biosimilar.

A trio of employer groups has formed a new partnership to advocate for policies that address the problem of high—and growing—drug costs.

As innovator biologics that have achieved blockbuster sales status reach or near the end of their exclusivities, biosimilar competition is close behind. This week, stakeholders got a closer look at how innovator drug companies are positioning themselves to maintain their sales in the face of such competition.

In a memorandum in support of its motion to dismiss the suit, AbbVie says that the complaint seeks to “upend the well-settled balance between the patent and antitrust laws,” that the complaint would end international early-entry patent settlements that do not have the same global market entry date, and that it would “chill medical and therapeutic innovation.”

Representatives Paul Tonko, D-New York, and Rob Gibbs, R-Ohio, have introduced H.R. 4629, the Star Ratings for Biosimilars Act, in the House. The bipartisan bill would require HHS to evaluate Medicare Advantage (MA) plans based on whether biosimilars are available to enrollees.

Genentech has announced that a phase 3 study of its brand-name rituximab, Rituxan, met its primary end point and demonstrated that treatment with rituximab is superior to treatment with mycophenolate mofetil in patients with moderate to severe pemphigus vulgaris (PV), a rate autoimmune disease that affects the skin and mucous membranes.

The MAGIC Act would amend the Affordable Care Act to allow chemically synthesized insulins to be approved under abbreviated new drug applications.