Biosimilars

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.

Pharmacists play an essential role in counseling patients on biosimilar substitution protocols and following state regulations regarding interchangeable medications.

Adalimumab biosimilars differ from adalimumab in approved indications, concentration and dosage, and formulation.

The new approval expands the portfolio of denosumab biosimilars, increasing access and improving costs for patients.

Although more research is needed in pediatric patients, biosimilars could improve treatment access and reduce costs.

The approval in multiple indications is designed to improve access to effective, proven treatments for skeletal fractures, which can greatly reduce patient quality of life.

Insulin-aspart-szjj (Merilog) is the first rapid-acting insulin biosimilar product approved by the FDA.

If approved, HLX11 could offer a more cost-effective alternative to pertuzumab for the treatment of human epidermal growth factor receptor 2-positive breast cancer.

The approval includes indications for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19.

This marks the first US biologic license application filing acceptance for a biosimilar candidate to golimumab.

Biosimilar use is not linked to an increased risk of treatment failure among pediatric patients with inflammatory bowel disease (IBD).