Biosimilars

The biosimilarity was evident between SB17 (Samsung Bioepis), ustekinumab (Stelara; Janssen Immunology), and those switching from ustekinumab to SB17.

Cardinal Health released its 2024 biosimilars report, including research and in-depth analyses on legislative development, payer landscapes, and new treatments in the pipeline.

Tocilizumab-aazg (Tyenne; Fresenius Kabi) is the first approved biosimilar to tocilizumab (Actemra; Genentech) as both intravenous and subcutaneous.

A phase 1 study previously demonstrated that MW032 and denosumab were bioequivalent in pharmacokinetics, pharmacodynamics, safety, and immunogenicity.

Denosumab-bbdz (Wyost; Sandoz) and denosumab-bbdz (Jubbonti; Sandoz) are approved as interchangeable for all indications of denosumab (Xgeva and Prolia; Amgen).

Jon Martin, US commercial lead of biosimilars at Organon, discusses how making their biosimilar Hadlima the preferred product on the Veteran Affairs formulary will help lower treatment costs.

Adalimumab-ryvk is the first high-concentration, citrate-free biosimilar to Humira that has been granted interchangeability status for the 40 mg/0.4 ml injection.

Dedicated clinical trials in IBD cohorts that scrutinized biosimilar use in real-world clinical practice have direct implications on decision making.

Despite the proven efficacy of biosimilars, both patients and health care providers often have some reluctance when switching from an originator drug to a biosimilar.

Since the first FDA biosimilar approval of filgrastim-sndz (Zarxio) in 2015, a total of 44 biosimilars for 15 originator products have been approved and more than 20 are marketed.

Fouad Atouf, senior vice president of global biologics at US Pharmacopeia, discusses the importance of robust quality standards in addressing concerns regarding biosimilar safety and efficacy.

The levels of disease activity after 6 months of tumor necrosis factor-α inhibitors could help predict the response to therapy at 4 years for those who have long-standing rheumatoid arthritis.

Bevacizumab is a recombinant humanized G1 monoclonal anti-vascular endothelial growth factor antibody that is used in combination with chemotherapy to treat solid tumors.

The company seeks the approval for both the intravenous and subcutaneous administration routes.

Switching from adalimumab originator to SB5 did not cause clinically significant differences in treatment efficacy and safety for patients with noninfectious uveitis.

The IQVIA Global Use of Medicines report for 2024 predicts that loss of brand exclusivity will negatively impact global market growth.

In 2024, there is an urgent need for policies that will accelerate biosimilar use to achieve lower system-wide health care costs.

Despite the insignificant differences in efficacy, biomarkers, therapeutic drug level, and ADAs, patients reported a significant number of nocebo effects.

Biosimilars are proven to be highly similar to the original products with no clinical meaningful differences.

Adalimumab-aqvh (Yusimry; Coherus Biosciences) entered the market in July 2023, following approval by the FDA in December 2021.

There was no statistically significant difference between Lovenox (Sanofi–Aventis Pharmaceuticals, France) and biosimilar enoxaparin in the occurrence of post-operative thrombosis for digestive cancer.

Liraglutide, a glucagon-like peptide 1 receptor agonist, has shown a clinically and significant reduction in glycated hemoglobin for those with type 2 diabetes.

From newsworthy moments to groundbreaking research, these were the most-read biosimilar-related articles on Pharmacy Times in 2023.

The biosimilars landscape is set to witness significant growth, particularly in therapeutic areas like ophthalmology and immunology, with a focus on blockbuster biologics like Humira, Stelara, and Eylea.

Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, discusses the dynamic landscape of the biosimilars market, providing key insights into its current status and future projections.