Biosimilars

Adalimumab biosimilar market shares have steadily increased, but challenges remain due to pricing strategies and limited government support, according to the Samsung Bioepis report.

Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.

Blue Shield of California will offer an adalimumab biosimilar at a price that is 75% less than the reference product Humira for the monthly dose.

Otulfi from Formycon and Fresenius Kabi was approved simultaneously in the US and the European Union. In the US, it will launch in February 2025.

A French study found that follitropin alfa, a biosimilar fertility drug, is more cost-effective compared with its originator, leading to potential savings for both patients and the health care system.

Out-of-pocket costs for biosimilars and generics are still high for patients despite these drugs leading to estimated savings of $445 billion in 2023.

The rates of discontinuation due to inefficacy or adverse events for biosimilars and originators of etanercept and adalimumab were similar, according to an analysis of a prospective registry.

Celltrion's adalimumab-aaty biosimilar is now accessible for all Costco members, while Amgen sues Samsung Bioepis over the latter’s denosumab biosimilar candidate, and GlycoNex progresses its denosumab biosimilar SPD8 to phase 3 trials.

Delayed biosimilar uptake in the US is driven by payer, provider, and patient barriers, but targeted interventions can help boost utilization and savings.

This article first appeared on The Center for Biosimilars®.

The FDA approved Sandoz’ Enzeevu, the fourth aflibercept biosimilar to be approved for Americans with age-related macular degeneration and other retinal eye diseases.

The FDA approved the first 2 biosimilars referencing aflibercept (Eylea). However, patent litigation has left it unclear when the biosimilars will come to market.

Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.

Patients with radiographic axial spondyloarthritis (ax-SpA) and a high risk of radiographic progression had similar low progression on both secukinumab and an adalimumab biosimilar.

Wyost and Jubbonti were approved as interchangeable biosimilars for Xgeva and Prolia; however, there is no launch date yet pending litigation with the maker of the reference products.

Biosimilars offer substantial promise for a new era of accessibility and affordability for patients and the broader health care industry, but better understanding of these products from payers and providers is necessary for biosimilars to reach their full potential in the US.

While the first ustekinumab biosimilar, Wezlana, was approved in October 2023, a settlement with Johnson & Johnson (J&J) will keep it off the market until 2025, preventing competition, and causing purchasers to pay substantially more for the agent.

The most popular content from our Asembia coverage largely covered biosimilars.

Through interviews and contributed content, Strategic Alliance Partnerships provide insights into changes in health care delivery and medicine.

Bio-Thera Solutions’ Avzivi (bevacizumab-tnjn) has become the fifth biosimilar referencing Avastin (bevacizumab) to be approved in the United States.

In 2023, adalimumab biosimilars took center stage in the biosimilar space due to 8 long-anticipated products finally launching.

The government of Australia’s pricing policy links the price of new medications with similar safety and efficacy, resulting in significant savings over the first 3 years after the etanercept biosimilar Brenzys was introduced.

Patients with inflammatory bowel disease (IBD) receive additional evidence on the safety and efficacy of adalimumab biosimilar GP2017 treatment.

ABP 959, an eculizumab biosimilar in development, has demonstrated similar efficacy and pharmacokinetics to the reference product for patients with paroxysmal nocturnal hemoglobinuria (PNH), according to research at the 2023 American Society of Hematology Annual Meeting.

A mandatory nationwide transition from reference adalimumab to a biosimilar was implemented in New Zealand.

As part of updates to its standard formulary, CVS Caremark has removed Amjevita and now prefers Hyrimoz and an unbranded biosimilar.

Health plan type highly influences the likelihood of biosimilar uptake, with low-flexibility insurance plans more likely to have patients who either switched to a biosimilar or were initiated on a biosimilar.

A simulation study estimated the impact of biosimilar substitution on total cost of care (TCOC) and provider financial performance in the final performance period of the Oncology Care Model.

HADLIMA is currently indicated for psoriatic arthritis, plaque psoriasis, and hidradenitis suppurativa, among others.

Reporting on the real-world utilization of reference rituximab and its biosimilars can help show prescribing habits and reveal cost-saving opportunities.