Oncology

The FDA granted a new indication for rheumatoid arthritis for Riabni, a rituximab biosimilar, and Organon and Shanghai Henlius Biotech entered into a licensing agreement for 2 oncology biosimilar candidates.

An analysis of retrospective data demonstrated comparable safety and efficacy profiles between CT-P6, a trastuzumab biosimilar, and Herceptin (reference trastuzumab) combined with chemotherapy and pertuzumab.

The Federal Trade Commission (FTC) will require the 6 largest pharmacy benefit managers (PBMs) to submit records and answer questions regarding their business practices.

Posters presented at the American Society of Clinical Oncology (ASCO)'s annual meeting showed the successful approaches health systems took to encourage greater adoption of oncology biosimilars.

The FDA approved Fylnetra, the fifth approval for a pegfilgrastim biosimilar in the United States.

The European Committee for Medicinal Products (CHMP) rejects Prestige Biopharma’s biosimilar referencing Herceptin; Prime Therapeutics’ plan to leverage biosimilars resulted in savings for patients; Samsung Biologics and AstraZeneca liquidated their joint venture (Archigen Biotech).

Viatris and Biocon Biologics announced the launch of their bevacizumab product, Abevmy, a biosimilar to Avastin, on the Canadian market.

Jeff Patton, MD, CEO and board member at OneOncology, dived into the controversial role that pharmacy benefit managers (PBMs) play in formulary decision-making and how PBMs impact biosimilar utilization.

Posters from the Academy of Managed Care Pharmacy (AMCP)’s annual meeting examined the real-world patterns of biosimilar utilization and the impact of products that have been reclassified as biologics on Medicaid spending.

During the Coherus Biosciences earnings call, the company announced that it was terminating its licensing agreement with Innovent Biologics for Byvasda, a bevacizumab biosimilar candidate referencing Avastin.

Stacie B. Dusetzina, PhD, is the Ingram Associate Professor of Cancer Research at Vanderbilt University Medical Center, and a member of the editorial board for The American Journal of Managed Care®.

New information on oncology biosimilars have sprouted during the month of April, including an FDA approval, study results from conferences, and data on pegfilgrastim biosimilar utilization and spending.

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.