Dermatology

FDA Approves Steqeyma: The Seventh Stelara Biosimilar

December 18th 2024

By Skylar Jeremias

Article

The FDA approved Celltrion's Steqeyma (ustekinumab-stba), making it the seventh biosimilar slated to compete against blockbuster Stelara (reference ustekinumab) in 2025.

Eye on Pharma: Golimumab Biosimilar Update; Korea Approves Denosumab; Xbrane, Intas Collaboration

December 10th 2024

By Skylar Jeremias

Article

Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.

Similar Persistence Rates Between Adalimumab New Starts, Switched Patients

December 7th 2024

By Deana Ferreri, PhD

Article

A French real-world study found that the adalimumab biosimilar SB5 was effective in treating rheumatic or gastrointestinal immune-mediated inflammatory diseases, showing no loss of disease control in switched patients and similar persistence rates between naive and switched groups.

Cost and Efficacy Insights on Infliximab Biosimilars in Pediatric Uveitis

December 3rd 2024

By Skylar Jeremias

Article

The study highlights the safety, efficacy, and cost benefits of infliximab biosimilars in managing pediatric noninfectious uveitis, showing fewer disease flares and reduced costs compared with reference infliximab, as well as the influence of insurance mandates on treatment decisions.

Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

November 7th 2024

By Skylar Jeremias

Article

For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.

Celltrion Sets Sights on 2030 With Expanded Biosimilar Portfolio, Market Reach

November 6th 2024

By Skylar Jeremias

Article

Celltrion plans to commercialize 22 biosimilars by 2030, expanding its global presence with robust sales growth driven by core biosimilars and new launches like subcutaneous infliximab.

How Policy Reforms in PBM Systems Could Change the Adalimumab Market

October 28th 2024

By Skylar Jeremias

Article

Panelists emphasized the need for transparency and policy reforms in pharmacy benefit management (PBM) to improve accessibility, affordability, and fair competition for adalimumab biosimilars.

Addressing Hesitance in Biosimilar Adoption

October 20th 2024

By Skylar Jeremias

Video

Sophia Humphreys, PharmD, from Sutter Health explains that expanding biosimilars into new therapeutic areas faces hesitance due to maintenance therapies, emphasizing the importance of education.

Phase 3 Study Reports Similar Efficacy Between SB17, Stelara in Psoriasis

October 19th 2024

By Deana Ferreri, PhD

Article

A phase 3, 28-week comparative clinical trial in patients with moderate to severe plaque psoriasis confirmed similarity of the proposed ustekinumab biosimilar SB17 (Samsung Bioepis) to the reference product (Stelara) in efficacy, safety, pharmacokinetics, and immunogenicity.

Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review

October 15th 2024

By Skylar Jeremias

Article

Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.