Dermatology

In a biosimilar trend report, Amgen discusses marketing achievements, US biosimilar policy, payer and provider acceptance of these agents, and the outlook for further growth.

Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer what the author considers a more "rational approach."

In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.

Animal toxicology studies still get included with biosimilar approval applications, although there are strong arguments that most of these studies are unnecessary. Sarfaraz K. Niazi, PhD, explains the pros and cons.

Misperceptions of biosimilars contribute to low acceptance of these products. Two Cardinal Health researchers discuss barriers to understanding and the importance of biosimilar education.

The International Psoriasis Council (IPC) reaches consensus on switching, patient agreement, and biosimilar safety and efficacy qualification. The IPC guidance is conservative when it comes to substitution of these products.

Semglee (insulin glargine) will be the first test of the FDA's interchangeability concept for biosimilars, but Viatris aims to grow its biosimilar revenues with multiple products.

Sophia Z. Humphreys, PharmD, MHA, explains how biosimilar utilization management can enable health care institutions to put COVID-19–related financial wreckage behind them.

In this column, officials from the Biosimilars Forum and Xcenda discuss how biosimilar competition has lowered prices of originator biologics and improved patient access.

Reverse switching occurs when patients transitioned to or initiated on a biosimilar are changed to an originator product, often because of a perceived failure in the biosimilar therapy.

Sarfaraz K. Niazi, PhD, a member of The Center for Biosimilars® Advisory Board, reports on his citizen petition to the FDA to rationalize testing of biosimilars.

Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.

The anatomy of an interchangeability switching study.

How much muscle did Congress invest in a pair of bills recently signed by President Biden? The answer may lie in your willingness to believe.

Medicinal packaging shouldn't remind patients that they have a condition, according to Samsung Bioepis.

The European Union is a diverse market with pockets of biosimilar resistance but also cost-saving triumphs, panelists said at the Biosimilar Medicines Virtual Summit 2021.

Anticipating roughly $26 million in annual savings, British Columbia's public payer PharmaCare is switching patients away from originator Humira.

New York Medicaid achieved 78% to 94% biosimilar utilization for 4 originator brands during a focused effort in 2019.

Opinions are diverse on how best to clear the obstructions to biosimilar market entry and patient access.

To overcome provider and patient preferences for brand originators, there has to be more of an incentive to use biosimilars, explains Nedzad Pojskic, PhD, MSc, Green Shield Canada.

An internationally recognized authority on biosimilar development discusses varieties of copy biologics in India and the need to distinguish these from true biosimilars.

The latest e-book from The Center for Biosimilars® offers insightful content on patient education, biosimilar development, and regulatory issues.

A renowned expert on the life sciences industry in the United Kingdom provides an insightful look at Brexit and the importance for the pharmaceutical sector.

Animal toxicology studies contribute little to demonstrations of biosimilarity and yet these studies frequently must be done to satisfy international regulatory requirements, investigators conclude.

Biosimilars are intended to save money for the health care system, but for many reasons, they are not succeeding in this mission, Harvard authors argue.

The Senate has passed a bill requiring the FDA to provide educational information that supports and promotes the adoption of biosimilars.

Unsustainably low prices for generics are preventing some manufacturers from producing them, while biosimilars are blocked by policies that favor originator drugs, the Association for Accessible Medicines (AAM) argues.

Biocon and Viatris edge closer to EU marketing authorization for a bevacizumab biosimilar, among other biosimilar business developments.

Biosimilars have come a long way, and their path has mirrored that of generics—fraught with obstacles. Still, a stronger embrace is needed from physicians and payers.

Three-fourths of patients who reverse-switched to originator infliximab from CT-P13 benefited, although it wasn't clear why the biosimilar treatment "failed."