Biosimilars

Senators Ron Wyden and Mike Crapo reaffirm their support on 2 health care bills that passed the United States Senate Committee on Finance in 2023.

The tool consolidates and highlights key features that would be considered when choosing a biosimilar adalimumab.

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).

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.

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 aim of developing GP40141 as a biosimilar is to help reduce the cost of the drug and make treatment more affordable for those with idiopathic thrombocytopenic purpura, according to investigators.

The legal and common uses of “interchangeability” continue to be conflated.

The sBLA was based on data from a clinical study assessing the pharmacokinetics of switching between adalimumab and adalimumab-bwwd for patients with moderate to severe plaque psoriasis.

The biosimilar, now legally available at the pharmacy level, demonstrated similar safety, purity, and potency to the reference product.

Infliximab-dyyb (Zymfentra; Celltrion USA) is a subcutaneous treatment for the maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn disease.

Biosimilars in the pharmacy benefit are as effective as their reference drug, but it’s important for the pharmacist to clarify this to patients.

The biosimilar landscape is growing, but the FDA should leverage analytical data to efficiently determine the quality of these products and propel them toward approval, according to a session at the Academy of Managed Care Pharmacy’s Nexus 2023 conference.