Biosimilars

These options are typically more cost-effective, enhancing patient accessibility

A provisional determination is also provided for the 40 mg/0.4 mL strength due to remaining interchangeability designation for another biosimilar to Humira.

Study participants’ overall satisfaction with a mandatory nationwide adalimumab transition in New Zealand varied but was generally low.

This citrate-free and high-dose approval of the biosimilar Humira provides another option to treat patients who are living with various inflammatory diseases.

With 50 biosimilar products approved by the FDA, questions arise regarding biosimilar lifecycles and sustainability of the industry.

The trial will compared the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and pembrolizumab for metastatic non-squamous non-small cell lung cancer.

Ustekinumab (Stelara; Janssen Immunology) is a human monoclonal antibody that treats immune-mediated diseases such as psoriasis and psoriatic arthritis.

There was no difference observed between adalimumab (Humira; AbbVie) and adalimumab-aacf (Idacio; Fresenius Kabi) for those who switched to the biosimilar.

In a review, investigators focused on ranibizumab (Lucentis; Genentech), aflibercept (Eylea; Regeneron), and bevacizumab (Avastin; Genentech) as growth opportunities in the biosimilar space.

The results indicate the need for targeted policies so that biosimilar competition can increase cost savings and affordability for patients with commercial insurance.

The BLA includes all indications for Xolair, including asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergy, and chronic spontaneous urticaria.

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.