Biosimilars

The FDA expands tocilizumab-anoh's approval for treating cytokine release syndrome (CRS), enhancing treatment options for patients aged 2 and older.

Herzuma shows promising efficacy and safety as a cost-effective biosimilar for treating HER2+ advanced gastric cancer, offering new hope for patients.

A recent study reveals Mvasi's comparable safety profile to Avastin for retinal diseases, highlighting the need for on-label biosimilars in ophthalmology.

Hospitals and health systems are adapting specialty and infusion pharmacy strategies to meet evolving payer mandates, rising costs, and shifting care models by expanding biosimilar use, optimizing prior authorizations, and integrating technology to enhance patient access and operational efficiency.

There were also no observed differences in retention rates or safety among patients with ankylosing spondylitis.

The biosimilar showed similar efficacy, pharmacokinetics, pharmacodynamics, safety, quality of life, and immunogenicity in patients with chronic spontaneous urticaria (CSU).

The agent, Kirsty, represents a more affordable alternative to Novolog.

Laura R. Bobolts, PharmD, BCOP, shares actionable strategies for oncology pharmacists to navigate biosimilar and 505(b)(2) drug implementation, manage payer and formulary complexities, and optimize cost-effective care delivery across oncology service lines.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC, FAPO, discusses how oncology pharmacists can lead value-based care efforts under the Enhanced Oncology Model (EOM) by improving care coordination, managing costs, aligning with performance metrics, and leveraging clinical data systems to enhance patient outcomes.

The study found biosimilar initiation rose to nearly 42% from 2016 to 2023.

Real-world data show that patients switching from Humira to biosimilars Hadlima and Hyrimoz achieve similar outcomes without hospitalization.

Some patients incorrectly believe that biosimilars compromise safety or efficacy.

Hulio shows comparable efficacy and safety to Humira in treating chronic plaque psoriasis, supporting its FDA interchangeability status.

The subcutaneous infusion is indicated for pediatric patients aged 6 to 17 years who weigh less than 60 kg.

Biologics and biosimilars have a major role in modern medicine because of their clinical benefits and economic impact on patient care.

The FDA designated Hadlima as an interchangeable biosimilar to Humira, enhancing patient access and potential savings for various conditions.

A new biosimilar to ustekinumab (Stelara) has been approved by the FDA, further expanding treatment options for patients with immune conditions such as plaque psoriasis and psoriatic arthritis.

Yuflyma gains FDA interchangeability with Humira, enhancing patient access to effective biosimilar treatments for various inflammatory conditions.

Omalizumab expands its role in allergy management, now FDA-approved for food allergies, showcasing potential for broader applications in allergic rhinitis.

Cimerli offers a promising biosimilar treatment for age-related macular degeneration, enhancing vision preservation with its effective VEGF inhibition.

This shift brings new responsibilities and opportunities, from managing inventory changes to counseling patients on alternative therapies.

The designation was supported based on data from the randomized, double-blind, active-controlled phase 3 interchangeability study.

This approval marks bevacizumab-nwgd as the sixth reference product to bevacizumab (Avastin).

Tocilizumab-bavi received FDA approval in September 2023 as the first biosimilar to tocilizumab for the treatment of various adult and pediatric arthritis conditions.

The biosimilar is approved for all indications of the reference products, Prolia and Xgeva.

The launch of ustekinumab-stba following its FDA approval expands patient access to this therapy with a variety of indications.