December 4th 2023
Sarfaraz K. Niazi, PhD, comments on a poll he conducted revealing that many are still hesitant to remove clinical efficacy study requirements for biosimilars in his latest column.
December 2nd 2023
A survey explores the experiences of health care providers (HCP) in New Zealand throughout the transition process following a mandatory switch from the adalimumab originator (Humira) to a biosimilar in 2022.
November 28th 2023
Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
November 23rd 2023
The legal and common uses of “interchangeability” continue to be conflated.
November 20th 2023
Sarfaraz K. Niazi, PhD, offers hope for the end of interchangeability labels in the United States in his latest column.
Dr Steven Yates Discusses the Need for Biosimilar Incentives in Community Oncology
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.
Samsung Bioepis White Paper Describes Biosimilar Barriers to Adoption
Stakeholder education programs and robust data on clinical studies are key to building patient and provider support for biosimilars, according to a new whitepaper.
EMA Reports on Pilot Study of Biosimilar Development Tailoring
European Medicines Agency (EMA) officials said their pilot was based on wrong assumptions about the biosimilar development process.
WHO Develops Clinical Trials Tailoring Approach for Biosimilars
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.
ICER: Humira's Price Increases in 2020 Were Unsupported by Clinical Evidence
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.
PRI Estimates Potential Biosimilar Savings in Freer Market Environment
The conservative think tank Pacific Research Institute (PRI) calculated potential biosimilar savings across multiple market share scenarios.
A UK Clinician Discusses Biosimilars in the Time of COVID-19
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.
Dr Steven Yates Weighs How Relationships Between Nurses, Patients Influence Biosimilar Acceptance
Steven Yates, MD, explains how the relationships that nurses have with patients can influence biosimilar acceptance.
COA Study: Biosimilars Have Broadened Patient Access in Oncology
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.
FDA Official Addresses Unanswered Questions About Interchangeable Biosimilars
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.
Expert Discusses Chinese Biosimilar Business Prospects in the European Union
A consultant who specializes in helping Chinese biosimilar companies market their products in the European Union discusses the challenges and opportunities.
Dr Steven Yates Shares His Institutions's Policies on Nonmedical Switching and New Biosimilar Starts
Steven Yates, MD, discusses Intermountain Healthcare's policies surrounding switching patients from reference products to biosimilars.
AAM Jousts With Rebate Penalties for Generics and 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 Joins Express Scripts in Moving Semglee to Preferred Formulary Status
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.
IGBA Describes Competitive Economics of Biosimilars Industry
Kicking off Global Biosimilars Week, the International Generic and Biosimilar Medicines Association (IGBA) released a blueprint detailing hurdles and opportunities for industry progress.
Pfizer to Seek Interchangeable Status for Abrilada Biosimilar
Pfizer reports on biosimilar revenues and says its switching studies for Abrilada, an adalimumab biosimilar, support interchangeable status.
Fresenius Kabi USA Executive Discusses Pegfilgrastim Biosimilar Prospects
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.
AmerisourceBergen/Xcenda Policy Experts Discuss Biosimilar Strategy
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.
Biosimilar Briefs: When to Switch to Biosimilars and More
An Emory pharmacy expert talks about the timing of switching to biosimliars, the Biosimilars Forum recommends biosimilars incentives, and Samsung Bioepis reaches a milestone.
An Interchangeable Biosimilars vs Authorized Biologics Battle May Be Looming
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.
Cate Lockhart Explores the Evolution of Biosimilar Barriers
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.
Survey: Moderate Acceptance of Anti-TNF Biosimilars Among Patients With Immune-Mediated Conditions
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.
Preferred Status for Semglee Will Test Value Proposition of Insulin Biosimilars
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.
Study: Basaglar "Biosimilar" Had Strong Downward Effect on Insulin Glargine Prices
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.
Specialty Biologics Report Predicts Rise in Biosimilar Access
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.
Gary Lyman, MD, MPH, Explores the Progress With Oncology Biosimilars
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 Review Marketed Adalimumab Biosimilars for Switching Differences
Investigators in Spain said they found no significant differences in outcomes for patients who switched from adalimumab originator to 1 of multiple adalimumab biosimilars.
Dose Adjustment, Infusion Interval Changes Hold Value for Patients With AS Treated With CT-P13
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).
Biosimilars Forum Launches State-by-State Savings Calculator
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.
EU Commission Enters Comment Phase of Plan to Improve Pharmaceutical Competition, Access
The European Commission is collecting comment on its multifaceted blueprint for broadening access to biologics and generic drugs and stimulating competition.
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