Biosimilars

Results are from an open-label extension of a phase 3 trial assessing the pharmacokinetics, efficacy, safety, and immunogenicity of adalimumab-aaty and its reference formulation Humira.

The FDA approved adalimumab-aaty in May 2023 for 8 indications, including rheumatoid arthritis, psoriatic arthritis, Crohn disease, ulcerative colitis, and plaque psoriasis.

Denosumab-bnht (Conexxence, Bomyntra) became the third biosimilar in 2025 to be approved for denosumab (Prolia, Xgeva).

Omalizumab-igec is approved to treat moderate to severe persistent asthma in patients 6 years and older whose symptoms are not well controlled with inhaled corticosteroids.

Denosumab-Bmwo is approved for all indications of the respective reference products, including osteoporosis and high-risk of fracture due to chemotherapy.

Yesintek from Biocon Biologics and Pyzchiva from Sandoz will have a patient assistance program that includes benefits verification and copay support.

Denosumab-dssb is approved as a 60 mg pre-filled syringe as a biosimilar for Prolia and 120 mg vial as a biosimilar for Xgeva.

The drug is the first rapid-acting insulin biosimilar product approved for use by the FDA, marking a significant milestone in diabetes treatment.

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist at the Mayo Clinic, discusses her career and how biosimilars will impact the pharmacy profession in the coming years.

A conversation with Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist at the Mayo Clinic.

Drug Topics met with Amanuel Kehasse, PharmD, PhD, to discuss the barriers surrounding biosimilar implementation in the prescription drug market.

On the most recent episode of Over the Counter, Steve Callahan, Senior Director of Advisory & Insights at MMIT, talked with us about biosimilars and the Inflation Reduction Act.

Steve Callahan, Senior Director of Advisory & Insights at MMIT, discussed out-of-pocket costs and the impact biosimilars are predicted to have for patients in the future.

Steve Callahan, Senior Director of Advisory & Insights at MMIT, sat down with Drug Topics to discuss industry trends behind biosimilars.

The cost effectiveness of biosimilar denosumab for postmenopausal osteoporosis varies significantly based on factors like adherence, subsequent therapies, and treatment duration.

The approval is supported by results from phase 3 multi-regional clinical trials conducted in patients with plaque psoriasis.

The approval of eculizumab-aagh offers more treatment options for patients with rare diseases PNH and aHUS.

The initiative by Boehringer and GoodRx has the potential to accelerate the therapeutic timeline for patients treated with the biosimilar.

Ustekinumab-ttwe, a biosimilar to ustekinumab (Stelara) is expected launch in the US in February 2025.

Eculizamab-aeeb is the 53rd FDA-approved biosimilar in the US.

These aflibercept biosimilars are used to treat wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.

Since biosimilars first launched, unique pricing incentives and strategies have been created to incentives adoption.

As medication experts, pharmacists can advocate to organizational decision makers around the benefits of biosimilars.

According to Michael Osso, president and chief executive officer of the Crohn’s & Colitis Foundation, “the flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicine.”

This approval is the second biosimilar approval for manufacturer Alvotech.

Despite the significant growth of biosimilars, their adoption across various therapeutic areas has remained slow.

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The biosimilar represents a comprehensive, accessible, and high-quality treatment option for patients in the US treated with tocilizumab.

The agency approved denosumab-bddz under two brand names: Wyost and Jubbonti.

Simlandi is the only biosimilar to Humira on the market that is high-concentration, citrate-free, and interchangeable.