Policy

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.

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.

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

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.

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.

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.”

Prime Therapeutics said that by putting Semglee (insulin glargine) on formulary, along with other biosimilars, it could achieve savings of $41 million or more per year.

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.

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.

Two AmerisourceBergen/Xcenda policy experts discuss the coming wave of pharmacy benefit biosimilars, formulary decisions, pricing transparency, and the Biden Administration’s push for lower-cost biologics.

An Emory pharmacy expert talks about the timing of switching to biosimliars, the Biosimilars Forum recommends biosimilars incentives, and Samsung Bioepis reaches a milestone.

Competitors in the field of adalimumab and insulin products may soon include “authorized biologics” in addition to biosimilars and interchangeable biosimilars, a pharmacy expert explains at the Academy of Managed Care Pharmacy Nexus 2021 meeting.

Reimbursement concerns and the uncertainty of how interchangeability will impact biosimilar adoption are hot-button issues in the biosimilar space, Cate Lockhart, PharmD, PhD, MS, explains in this interview.

Patients with and without experience with tumor necrosis factor (TNF)–blocker biologics have incomplete knowledge of biosimilars for these agents, according to findings presented at the Academy of Managed Care Pharmacy 2021 Nexus meeting.

Hopes that insulin biosimilars can improve access and affordability will be tested by Express Scripts’ plan to give preferred formulary status to Semglee, a long-acting insulin that is interchangeable with Lantus.

Over a 10-year period, Basaglar, considered an unofficial biosimilar, achieved price drops in the insulin glargine market and took a significant market share from Lantus.

The report from CoverMyMeds, a division of McKesson, discusses payer/pharmacy benefit manager consolidation, patient adherence, white bagging, and other issues common to specialty pharma.

Oncology biosimilars are broadly in use for good reason: They're absolutely vital for cost reduction and access, but efforts are needed to promote uptake of these agents, says Gary Lyman, MD, MPH, in this interview.

Investigators in Spain said they found no significant differences in outcomes for patients who switched from adalimumab originator to 1 of multiple adalimumab biosimilars.

Investigators said the RAAS study filled in missing information on the value of dose modulations and infusion interval changes for patients with ankylosing spondylitis (AS) treated with CT-P13 (Remsima, Inflectra).

An interactive tool from Biosimilars Forum, an industry group, uses data from Pacific Research Institute to calculate potential biosimilar savings based on 75% market share.

The European Commission is collecting comment on its multifaceted blueprint for broadening access to biologics and generic drugs and stimulating competition.

Preventing the nocebo effect requires a demonstration of confidence in biosimilars from all health care practitioners, including pharmacists, experts said in a newly published rheumatology treatment guidance document.

Studies of the infliximab biosimilar Remsima in patients with inflammatory bowel disease were presented at United European Gastroenterology Week 2021.