Biosimilars

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.

Additional education can address ambivalence for patients and providers, which can start at the pharmacist level, as they are essential sources of information for patients.

For biosimilars to overcome these entrenched market dynamics, they must not only compete on price but actively work to build a network of support among providers and patients.

Investigators obtained real-world evidence to evaluate the clinical outcomes of non-medical switching from the infliximab (Remicade; Janssen Immunology) to a biosimilar.

P043 is currently approved for patients 6 years and older with moderate to severe persistent allergic asthma whose disease is inadequately controlled with inhaled corticosteroids.

High-cost novel therapies challenge payers and patients, while biosimilars help balance affordability.

The guidance, if finalized, would revise considerations about switching studies for proposed interchangeable biosimilars.

Biosimilar etanercept (Sunshine Guojian Pharmaceutical) showed similar therapeutic outcomes compared with etanercept (Enbrel; Amgen) specific to rheumatoid arthritis.

The biosimilar space continues to grow, with key focuses around retina and oncology, but adoption remains slow in the United States.

The treatment is indicated to improve and maintain visual acuity in individuals with neovascular age-related macular degeneration.

Investigators find that this could suggest the biosimilar uptake alone may not be a complete measure of the market competition and lowering prices.

A report from SkyQuest Technology highlights the growth in the oncology and insulin spaces, indicating they will contribute to the most growth.

The similarities were shown for both the US formulation and the EU formulation.

Patients without insurance may not be able to afford the biosimilar adalimumab-adbm, even if it is available at a more affordable price than its reference product.

Eculizumab-aagh does not have an interchangeable designation, though that could be updated in the future.

The number of FDA-approved biologics has exploded, and biosimilars are making their mark

Switching from aflibercept (Eylea; Regeneron Pharmaceuticals) to biosimilar ranibizumab (Lucentis; Genentech) for neovascular age-related macular degeneration could be more cost effective for patients.

After failure with methotrexate, treatment with leflunomide is typically recommended, but treatment with biosimilars could have greater quality-adjusted life years.

Following the previous FDA approval of faricimab-svoa to treat some of the leading causes of vision loss, the Administration has approved a single-dose prefilled syringe of the drug which could lead to safer and more efficient administration while easing patient burden.

Ustekinumab-ttwe (Pyzchiva; Sandoz) is approved for all of the same indications as Stelara.

The European Union (EU) has successfully created a competitive market for biosimilars, while the US faces challenging market dynamics and tactics by pharmacy benefit managers that hinder the adoption of lower-cost therapies.

Health professionals have expressed concerns regarding consistent naming standards, the regulatory process surrounding the approval of biosimilar drugs, and the lack of education they have about biosimilars.

Investigators compared the reference products of adalimumab (Humira; AbbVie) and etanercept (Enbrel; Amgen) with biosimilar products.

The new findings were presented as an oral presentation at the 2024 European Calcified Tissue Society Congress, held from May 25, 2024, to May 28, 2024.

FKS518 (Fresenius Kabi) would be indicated for the treatment of osteoporosis in men and women, including glucocorticoid-induced osteoporosis and bone loss due to prostate or breast cancer.

Eculizumab-aeeb (Bkemv; Amgen) is approved for the treatment of paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.