Rheumatology

Getting to the stage where clinical data on interchangeability are reportable to the FDA is a key milestone in Alvotech’s bid to get its high-concentration adalimumab biosimilar approved and on the market.

The “winner-takes-all” tender process for biosimilar procurement in the European Union runs the risk of driving competitors out of the market, authors of a new survey contend.

Product differentiation, global partners, and a large suite of biosimilars in development are ways that Reykjavik, Iceland-based Alvotech expects to stay ahead of the competition.

Postmarketing retrospective studies of the rituximab biosimilar (CT-P10, Truxima) demonstrated comparable safety and efficacy for treatment of diffuse large B-cell lymphoma (DLBCL).

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

In part 2 of this panel discussion, 3 experts on India’s biologics industry discuss whether biosimilars can be produced affordably in the country and ways of improving the industry’s image.

The European Union makes it far more difficult to obtain patents on biologics, reducing the likelihood of patent “thickets” that stifle competition, the Matrix Global Advisors report states.

In part 1 of this panel discussion, 3 experts on India’s biologics industry explain what’s missing from current biosimilar regulation and what the country needs to do for its products to compete internationally.

Bio-Thera has set up a psoriatic arthritis clinical trial for BAT2506, which references Simponi.

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.