News

The United Kingdom has approved STADA Arzneimittel and Xbrane Biopharma’s Ximluci, a ranibizumab biosimilar referencing Lucentis, for the treatment of retinal conditions.

Health Canada has granted approval for Celltrion Healthcare’s bevacizumab biosimilar (Vegzelma) referencing Avastin for the treatment of multiple forms of cancer.

The China National Medical Products Administration (NMPA) approved Bio-Thera Solutions’ tocilizumab biosimilar (BAT1806) referencing Actemra for the treatment of several rheumatic conditions.

In his column, Sarfaraz K. Niazi, PhD, chronicles the potential for biosimilars referencing some of the biggest cell and gene therapies as well as why companies should begin looking into biosimilar development efforts in this space.

Michael Chiang, MD, director of the National Eye Institute, discusses how his team is working to instill greater confidence in ophthalmology biosimilars among wary ophthalmologists.

A case study outlined a pediatric case of scalp and nail psoriasis, which was successfully treated with an adalimumab biosimilar and monitored with in vivo reflectance confocal microscopy.

Here are the top 5 biosimilar articles for the week of January 9, 2023.

A study assessing uptake rates and prices of biosimilars found that while the United States had significantly higher prices, the uptake in Germany and Switzerland, 2 European countries with national mechanisms for drug price negotiation, was slower.

Alvotech announced that a phase 1 pharmacokinetic study for its golimumab biosimilar referencing Simponi has commenced.

Coherus Biosciences has acquired an aflibercept biosimilar; the FDA has sent Biocon Biologics a complete response letter (CRL) regarding its insulin biosimilar; Lannett provides an update on the development of its insulin glargine and insulin aspart biosimilars.

IQVIA’s eighth edition of its Impact of Biosimilar Competition in Europe report demonstrated successful uptake in many countries throughout the region. However, not every country has great adoption rates and companies may have a harder time choosing which molecules to invest in for biosimilar development.

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, demonstrates why regulatory bodies in the United States shouldn't look at economic evaluations when reviewing regulatory data for biosimilars in his latest column.

Chelsee Jensen, PharmD, pharmaceutical formulary manager at the Mayo Clinic, explains what health organizations and health systems can do to better manage and instill confidence in biosimilars.

The authors of an retrospective real-world study of patients with hidradenitis suppurativa treated with adalimumab concluded that switching patients between adalimumab products risked a greater likelihood of loss of effectiveness.

Alvotech, an Iceland-based company, announced that the FDA accepted its biologics license application (BLA) for its proposed ustekinumab biosimilar referencing Stelara. The company said it expects the FDA’s decision in the second half of 2023.

Here are the top 5 biosimilar articles for the week of January 2, 2023.

Celltrion Healthcare submitted a biologics license application (BLA) to the FDA for its biobetter of its infliximab biosimilar allowing for subcutaneous administration (Remsima SC).

Sarfaraz K. Niazi, PhD, summarizes some of the lessons that the entire biosimilar industry can take away from 2022, including what new legislation and policy changes could mean for future biosimilar development.

Health Canada has approved the high-concentration version of Samsung Bioepis and Organon’s Hadlima, a citrate-free adalimumab biosimilar referencing Humira.

Biosimilar news in ophthalmology throughout the year tended to focus on the advancements of ranibizumab biosimilars, such as the US launch of Byooviz, the recall of a biobetter of ranibizumab, and the UK approval of Ongavia.

To say goodbye to 2022 and welcome in the new year, The Center for Biosimilars recaps the biggest news stories and milestones from the past 12 months as well as list of the top 5 podcast episodes of the year.

A study assessing the use of tumor necrosis factor (TNF) alpha inhibitor biosimilars in France found that the biosimilar penetration rate was higher for infliximab compared to etanercept and adalimumab. The authors said they aimed to understand the key drivers for biosimilar use to improve biosimilar uptake in France.

Conferences throughout 2022 shared new information on white bagging, the safety of biosimilar substitution, the use of a biobetter, and discussion around the role that pharmacy benefit managers play in biosimilar adoption.

News surrounding biosimilars referencing Humira (adalimumab) topped the list of biosimilar articles related to rheumatology in 2022, highlighting the excitement for these biosimilars to launch starting in early 2023.

Ian Henshaw, senior vice president and global head of biosimilars at Biogen, shares his thoughts on whether clinical efficacy and switching studies to establish biosimilar safety are necessary, a hotly debated topic in the biosimilars industry.

The American Journal of Managed Care, a sister site of The Center for Biosimilars, looked back at some of the most popular biosimilars content of 2022 to be published on AJMC.com.

The top 5 most-read articles about oncology within the biosimilars industry involved a number of FDA approvals and new data on the market impact of biosimilar competition on Roche’s blockbuster reference products.

John Gabrielson, senior vice president at JSR Life Sciences and head of Similis Bio, shares his perspective on how clinical efficacy testing and recent actions from the Biden Administration, such as the executive order on biotechnology investment, impact biosimilar development.

The “biosimilar-like” insulin glargine Basaglar was not less expensive for patients than the reference product, Lantus, concluded the authors of a retrospective analysis of commercial pharmacy claims and pharmacy co-payment offsets.

Here are the top 5 biosimilar articles for the week of December 19, 2022.