Oncology

Although Roche’s earnings report for the first quarter of 2022 showed overall increases, products like Herceptin, Avastin, and Rituxan continue to lose revenue due to biosimilar competition.

Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting highlighted the clinical similarity of a trastuzumab biosimilar compared with its reference product and real-world longitudinal application of infliximab biosimilars.

Medicare Part D plans missed out on between $84 million and $143 million in savings by not prioritizing the use of biosimilars over reference products, according to a report from the HHS Office of Inspector General.

An analysis of real-world dosing and effectiveness of pegfilgrastim biosimilars found the clinical benefits of preventing febrile neutropenia in patients with intermediate to high risk come at acceptable financial costs compared with filgrastim biosimilars.

Amneal said the product, to be sold under the name Alymsys, is the second of 3 US biosimilars the company expects to see approved this year.

If approved, Celltrion's CT-P16 would be the fourth bevacizumab biosimilar to reach the market.

Switzerland-based company Fresenius Kabi announced that its pegfilgrastim biosimilar received marketing authorization in Europe and that it has obtained a majority stake in biosimilar manufacturer mAbxience and acquired its subsidiary.

Edward Arrowsmith, MD, discussed his recent paper on the use of clinical pathways for specific cancer types and how biosimilar development can help ensure quality of care for patients with limited therapeutic options.

With white bagging, pharmacy benefit managers (PBMs) require certain high-cost drugs to be shipped from their own specialty pharmacies to practices, where clinicians then administer the drugs to patients.

Chelsee Jensen, PharmD, and Eric Tichy, PharmD, MBA, who coauthored a paper on the Mayo Clinic's success with implementing biosimilars, discuss their study and how their practice is expected to evolve to improve its approach.

During a session at the Academy of Managed Care Pharmacy annual meeting, Yuqian Liu, PharmD, of Magellan Rx Management, highlighted strategies to encourage biosimilar utilization in the oncology space and the cost savings as a result.

A series of initiatives to improve uptake of the biosimilars for 7 originator biologics resulted in significant savings for Providence St. Joseph Health.

An international phase 3 study of patients with erb-B2 receptor tyrosine kinase 2-positive (ERBB2+) breast cancer showed that Tuznue, a trastuzumab biosimilar, had comparable safety and efficacy to the reference product (Herceptin).

As HHS prepares to begin a study that will summarize the use and spending of biosimilars within Medicare Part B plans, the FDA updates its clinical trial guidance to expand enrollment access to senior patients.

Pfizer’s trastuzumab biosimilar (trastuzumab-qyyp; Trazimera) was stable and efficacious under conditions of extended use in patients with breast cancer, investigators concluded.

At a session at the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, panelists suggested that the quest for rebates by pharmacy benefit managers (PBMs) prevents uptake on some biosimilars—and could soon bleed over into biosimilar formulary placement.

Teva’s launch makes it the first competitor to Revlimid in the United States, but perhaps not the last.

Releuko, a filgrastim biosimilar developed by Kashiv Biosciences and Amneal Pharmaceuticals, has received FDA approval, the first of 2022.

Tuznue, which references Roche’s Herceptin, is currently under review for marketing authorization by the EU European Medicines Agency, Canada, and South Korea.

A report from AHIP found 3 drugs that have multiple biosimilars available can be delivered more affordably through specialty pharmacies.

Coherus released its earnings report for the last quarter of 2021 and for the year as a whole.

The year 2022 “is set to be a turning point” in the United States, as biosimilars are on their way to delivering $133 billion in aggregate savings by 2025, according to Cardinal Health's “2022 Biosimilars Report: The U.S. Journey and Path Ahead.”

Health Canada approves Ontruzant, the fifth Samsung Bioepis biosimilar to be approved for the Canadian market.

The authors noted that “all biologic therapeutics can be immunogenic or elicit an immune response,” and that an assessment of immunogenicity is part of the totality of evidence required for regulatory approval of biosimilars.

US biosimilar uptake faces several barriers, including misconceptions regarding biosimilar efficacy and a misalignment of prescription incentives between payers, providers, and patients, panelists discussed.

Sean McGowan, senior director of Biosimilars for AmerisourceBergen, forecasts potential biosimilar approvals and launches in 2022 as well as offers insights into how emerging biosimilars will impact the market and pricing in the coming years during an interview.

Two biosimilars, Pfizer’s Zirabev and Amgen’s Mvasi, have been approved for indications including unresectable, locally advanced NSCLC and recurrent or metastatic nonsquamous NSCLC. BI 695502 is no longer under development by Boehringer Ingelheim.

Records show the biosimilar for bevacizumab was used to treat both new patients and those already receiving care with the reference product.

The International Generic and Biosimilar Medicines Association has appointed a veteran member, Vivian Frittelli, MBA, ACIS, to take over as chair.

Ford Motor saved $5 million by switching patients to 5 biosimilars, and other manufacturers and employers in Michigan have achieved good results with switching programs, the Economic Alliance of Michigan reports.