Regulatory

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

An economist weighs in on whether interchangeable status will help adalimumab biosimilars succeed.

Alvotech has received European Commission (EC) approval to begin marketing its adalimumab biosimliar AVT02, the company announced this week.

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.

In a review, Sandoz researchers discuss lingering barriers that prevent insulin prices from falling to more affordable levels.

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.

In the second setback this year for etanercept biosimilars, the US District Court for the District of New Jersey has ordered Samsung Bioepis to delay marketing Eticovo until 2029.

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.

Authors of a review discuss barriers to insulin access and potential solutions as the 100-year anniversary of the drug's first use for diabetes gets closer.

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.

European Medicines Agency (EMA) officials said their pilot was based on wrong assumptions about the biosimilar development process.

The World Health Organization (WHO) has issued a fresh draft of its biosimilar evaluation guidelines. Medicines for Europe science and policy expert Marta Baldrighi, PhD, explains the significance.

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.

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.

Steven Yates, MD, explains how the relationships that nurses have with patients can influence biosimilar acceptance.

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.

A consultant who specializes in helping Chinese biosimilar companies market their products in the European Union discusses the challenges and opportunities.

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

Steven Yates, MD, discusses Intermountain Healthcare's policies surrounding switching patients from reference products to biosimilars.

As House leaders sought to build support for the Build Back Better Act, the Association for Accessible Medicines (AAM) objected to drug price negotiations and proposed “rebate penalties.”

Kicking off Global Biosimilars Week, the International Generic and Biosimilar Medicines Association (IGBA) released a blueprint detailing hurdles and opportunities for industry progress.

Pfizer reports on biosimilar revenues and says its switching studies for Abrilada, an adalimumab biosimilar, support interchangeable status.

The second interchangeable biosimilar approval, estimates of biosimilar savings, and competition for ranibizumab biosimilars characterized the month's developments.

Ali Ahmed, senior vice president of biosimilars for Fresenius Kabi USA discusses FDA review of the company’s Stimufend pegfilgrastim biosimilar candidate and the marketing of this product.