Regulatory

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.

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.

The arrival of Susvimo, an ocular implant for treatment of macular degeneration, poses a challenge for ophthalmic reference products and biosimilars.

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.

The company said growth into new biosimilar markets fueled revenue growth during the quarter just ended. It is also working to correct factory problems identified in a September FDA inspection.

Pharmacists need to brush up on their knowledge of the interchangeable biosimilar designation, investigators said in a survey presentation at the Academy of Managed Care Pharmacy Nexus 2021 meeting.

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.

The interchangeable designation allows pharmacists more flexibility to dispense this potentially money-saving product and gives Boehringer Ingelheim a marketing edge.

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 Center for Biosimilars® speaks with Polpharma Biologics executives Alex Moulson, vice president of Development, and Pawel Lewinski, head of Portfolio and Commercial Strategy, about the company's biosimilar pipeline.

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

Biosimilar development companies report an approval in Canada and positive phase 3 findings in China for their bevaciumab biosimilars.