Oncology

The year 2021 brought several firsts in biosimilars and set the stage for expansion across therapeutic areas including diabetes and ophthalmology.

A trio of regulatory experts discuss the current standing of biosimilar policy in the United States and expectations going forward.

Investigators said pathologic complete response (pCR) improved in a trastuzumab biosimilar/pertuzumab trial when patients were preselected for a subtype of breast cancer.

Investigators said more evidence would help to convince clinicians of the safety of switching between biosimilar products.

Xbrane Biopharma of Stockholm, Sweden, said its next biosimilar candidates will target the demand for oncology and hematology therapeutics.

In metastatic breast cancer (mBC) resistant to multiple lines, Herzuma (a trastuzumab biosimilar) plus gedatolisib, an mTOR/PI3K signaling pathway inhibitor, demonstrated value.

After a switch to a biosimilar, patients and their oncologists may not always agree on how well the switch was described or whether the patient felt involved.

Etanercept and adalimumab biosimilar competition is not only necessary to drive down prices, it’s long overdue, according to Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute.

Tot Biopharm receives China regulatory approval for a bevacizumab biosimilar and Fujifilm moves forward with plans for a Suzhou Innovation and Collaboration Center.

The trial included "drifted" (nonstandard) reference product, forcing a stratified analysis to yield relevant data.

Ahead of sales and revenues, Icelandic company Alvotech lines up a massive capital investment and an initial public offering (IPO).

The arrival of biosimilars for filgrastim and pegfiltrastim coincided with higher use of granulocyte colony-stimulating factor (G-CSF) for prophylaxis against febrile neutropenia, but many high-risk patients still do not receive the treatment.

A trastuzumab biosimilar candidate demonstrated equivalence to Herceptin in patients with early-stage human epidermal growth factor receptor 2 (HER2)–breast cancer.

Henlius gains approval in China for Hanbeitai and officials discuss combination therapy options with experimental therapy serplulimab and ophthalmology treatment.

Steven Yates, MD, an oncologist and medical director at Intermountain Healthcare, discusses problems underlying the 340B Drug Pricing Program.

Researchers report findings that suggest a different reimbursement system for Medicare Part B biologics could lead to significantly more robust savings.

Regulators are at work clarifying biosimilar guidance and on Capitol Hill, a battle is raging over reforms that could help or hurt biosimilar advancement.

Specialty tiers for biosimilars and reforms that address the proliferation of poor-quality patents would help lower costs and improve access, biosimilar industry veterans said.

An expert on biotherapeutics recommends more science be applied to World Health Organization (WHO) biosimilar guideline revisions.

Progression-free survival (PFS) was improved for patients with epidermal growth factor receptor–mutated nonsquamous non–small cell lung cancer who were treated with PD-1 and antivascularization therapy.

The utilization rates for biosimilars in community oncology have been much higher than for other disease categories and are only expected to rise, says Steven Yates, MD.

Stakeholder education programs and robust data on clinical studies are key to building patient and provider support for biosimilars, according to a new whitepaper.

The Institute for Clinical and Economic Review (ICER) states in its latest Unsupported Price Increase report that when it comes to rising drug prices, Humira is in a class of its own.

The conservative think tank Pacific Research Institute (PRI) calculated potential biosimilar savings across multiple market share scenarios.

Martin Perry, MBChB, BSc, MMEd, FRCP, clinical medical director for the National Health Service in Greater Glasgow and Clyde, Scotland, explains frontline care with biosimilars during COVID-19.

Kathy Oubre, MS, a cochair of the biosimilars committee of the Community Oncology Alliance (COA), explains findings from a broad study of biosimilar use in oncology practices.

In its first quarter of independence from Pfizer, Organon saw growth in biosimilars revenue; Sandoz' biosimilar portfolio has been touted as a growth driver amid talk of a spinoff from Novartis.

Sarah Yim, MD, provided a point-by-point overview of the FDA's efforts to clarify the role of the interchangeable biosimilar designation, improve communication with manufacturers, and pay for biosimilar regulatory reviews.

Janet Woodcock, MD, acting commissioner of the FDA, said the agency is meeting with biosimilar developers for biosimilars for 46 reference products.

In its third quarter earnings report, Amgen addressed the give and take of biosimilar competition.