Biosimilars

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).

The US health care market faces transformative changes in 2025, as biosimilars, GLP-1s, and new pharmacy economics reshape how benefit managers balance innovation with affordability.

Successfully integrating biosimilars into practices requires careful planning and execution, as they impact virtually all aspects of a practice.

Serplulimab plus HLX04 demonstrates a favorable safety profile in patients with advanced hepatocellular carcinoma.

Adherence to thiopurine medications after 6 months of use was 87.9% under direct pharmacist care but 65.7% under general practitioner guidance.

Ustekinumab-stba (Steqeyma; Celltrion) is a subcutaneous treatment for adult and pediatric patients with plaque psoriasis arthritis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

The tool is designed to address the nocebo effect, which was a concern of prescribers and other health care professionals.

Investigators presented additional data from a clinical trial at the American College of Rheumatology Convergence, demonstrating similar safety for postmenopausal women with osteoporosis.

The biosimilar is approved for the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

However, the monthly expenditure was not significantly associated with the financial incentives.

There were 2 main types of switches, including switching to rituximab subcutaneous and switching among different intravenous rituximab treatments.

Ocrelizumab (Ocrevus; Genentech) is used for the management and treatment of multiple sclerosis.

Pegfilgrastim (Neulasta; Amgen) treats neutropenia that is caused by cancer medications and helps the bone marrow to create new white blood cells.

HLX14 (Organon) is an investigational biosimilar to denosumab (Prolia/Xgeva; Amgen).

Pharmacists play a key role when it comes to medication substitution, especially for interchangeable biosimilars where allowed by state law.

The FDA previously accepted the biologic license application for CT-P13 as a subcutaneous formulation.

In April 2024, the FDA approved ustekinumab-aekn as a subcutaneous injection for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis.

Imuldosa has received approval for all indications of its reference product, including ulcerative colitis, psoriatic arthritis, and Crohn disease.

Formularies have become one of the biggest barriers to realizing the cost-saving potential of biosimilars.

In May 2024, the first biosimilars for aflibercept were approved, which included aflibercept-jbvf (Yesafili; Biocon Biologics), known as MYL-1701P.

Ustekinumab is a human monoclonal antibody targeting the cytokines interleukin (IL)-12 and IL-23, which play a rule in the inflammatory and immune responses.