Rheumatology

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.

Investigators in the Netherlands observed that 13.7% of patients with rheumatic disease had switched back to etanercept originator at 4.4 years from baseline.

Organon will do marketing but not research and development, Biogen and Bio-Thera move forward with tocilizumab candidate, and Lupin promotes a pegfilgrastim biosimilar.

Immunogenicity was rare but concerning for patients who switched from originator rituximab to the biosimilar Riximyo, investigators reported.

Real-world clinical data compiled for patients with autoimmune disorders were presented at EULAR 2021.

Celltrion announces the launch timing for its much anticipated high-concentration formulation of adalimumab and presents trial data supporting equivalence to the reference product.

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.

In part 2 of this interview, Cate Lockhart, PharmD, PhD, executive director of the Biologics and Biosimilar Collective Intelligence Consortium, discusses the potential for interchangeable insulin biosimilars and the challenges of obtaining reliable and optimized real world data.

BioFactura has specialized in biodefense agents for smallpox and Marburg virus, but sees revenue potential in biosimilars.

More transparency in how health care money is spent could improve utilization and efficiency, panelists said at the Medicines for Europe event.

In part 1 of this interview, Cate Lockhart, executive director of the Biologics and Biosimilar Collective Intelligence Consortium, details some of her expectations for further growth of the US biosimilar market.

The pandemic interrupted health care for many patients and saddled health care institutions with high costs. How might biosimilars improve conditions?

Investigators in British Columbia surveyed patients for their impressions of biosimilars before and after mandatory switching.

Adjusting for variables, investigators found little difference in disease outcomes for patients who switched to the infliximab originator vs biosimilars.

China’s streamlined system for biologics approvals has enabled Shanghai Henlius Biotech to bring biosimilars to market faster and potentially at a lower cost, Ping Cao, vice president of Business Development, explains.

Prestige BioPharma aims to expand its drug pipeline with a $152 million research and development facility.

A study funded by AbbVie finds support for maintaining patients on originator rheumatic agents, such as Humira (adalimumab), rather than switching to biosimilars.

Accused of unfair trade practices, AbbVie's CEO Richard Gonzalez pointed the finger at Medicare Part D.

The House Committee on Oversight and Reform contends AbbVie's "biosimilar defense strategy" has succeeded beyond the company's wildest imagination.

Originator company Amgen has won another round in defending its lucrative etanercept franchise, but the decision is sure to intensify scrutiny of extended patent protections.

Investigators evaluated both biosimilar vs originator savings and savings from earlier use of a lower-cost adalimumab biosimilar (Amgevita).

After being sued for allegedly stealing adalimumab process information, Alvotech fires back.

Investigators ranked biologics and Janus kinase 1 inhibitors based on past findings.

Advances in analytical testing have improved confidence in biosimilars, according to a Medicines for Europe panel.

The anatomy of an interchangeability switching study.

Amgevita is now broadly available across Canada.

Representative Carolyn B. Maloney, D-New York, questions the use of pharmaceutical profits to defend against biosimilar competition.

Biocon tests the waters with itolizumab in pandemic-ravaged India, and Celltrion announces early success with an agent for the South African variant.

There's no end in sight for Enbrel (etanercept) sales erosion, but Amgen's biosimilars are holding their own, the company reported.