Dermatology

Regulators and manufacturers advance biosimilars for aflibercept, omalizumab, and dupilumab, enhancing access to treatment in Europe and Latin America.

Celltrion's FDA approval of Steqeyma enhances pediatric psoriasis treatment, offering flexible dosing options for children with chronic inflammatory conditions.

Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans Humira biosimilar over patent dispute, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan.

The new data were collected to fulfill the FDA's requirements to designate adalimumab-fkjp (Hulio) as interchangeable with Humira, enhancing access to affordable biologics for chronic plaque psoriasis treatment.

Switching from reference ustekinumab to biosimilar FYB202 maintained comparable efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.

New research highlights the efficacy and high patient satisfaction of adalimumab biosimilars in treating inflammatory diseases.

The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.

Despite a dramatic shift toward biosimilar use following British Columbia’s policy, researchers found no rise in hospital visits or complications, underscoring the real-world reliability of etanercept biosimilars in managing inflammatory arthritis.

Dose escalations were more frequent with ustekinumab in patients with psoriasis compared with adalimumab and etanercept, highlighting varied outcomes for dose optimization in psoriasis management.

Australia’s growing reliance on high-cost biologics for inflammatory skin diseases has placed significant pressure on its health system—but a new report suggests biosimilars could offer financial relief, provided uptake barriers are addressed through policy reform and education.

A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.

A plain language summary for patients explains there were no differences in safety outcomes between adalimumab-adbm and the originator in a pooled analysis of the VOLTAIRE clinical trials.

Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.

During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.

High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US, particularly in formulary-driven transitions, as shown in 2 retrospective studies presented at the Academy of Managed Care Pharmacy annual meeting (AMCP 2025).

Switching between adalimumab products does not affect drug effectiveness or treatment duration in patients who have psoriasis, according to a Danish study.

Tendering emerged as the most effective strategy for reducing costs and increasing biosimilar uptake in the retail setting, while price-linked discounts and prescribing quotas have shown mixed or uncertain results.

Patients with moderate to severe plaque psoriasis who switched between the adalimumab biosimilar GP2017 and reference adalimumab did not impact immunogenicity, safety, or efficacy following up to 4 switches between both drugs.

Biocon’s ustekinumab biosimilar matched reference ustekinumab in efficacy and safety, while an adalimumab biosimilar proved interchangeable with reference adalimumab, according to posters at the American Academy of Dermatology (AAD) annual meeting.

Celltrion and Formycon with Fresenius Kabi launched their respective ustekinumab biosimilars (Steqeyma and Otulfi), joining 4 others that launched earlier this year.

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

The Department of Veterans Affairs (VA) saved $67 million in 2023 through its strong adoption of biosimilars to curb the high costs of biologic therapies to treat chronic disease.

2025 marks a pivotal year for biosimilars with Amgen's Wezlana leading ustekinumab biosimilar launches, potentially driving savings and access, as highlighted by Dracey Poore, MS, of Cardinal Health.

Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.

January 1 marks the launch of the first biosimilar referencing Stelara (ustekinumab) in the US, ushering in a new class of lower-cost medicines for patients with rheumatic and gastrointestinal conditions.

SB5, an adalimumab biosimilar approved in the US, is showing to be safe and effective for patients with psoriasis in the long term, according to a study from the UK and Ireland.

Three players in the biosimilar space have already sparked hope for the new year, with each having big business or regulatory announcements regarding new biosimilar products in Europe and Canada.

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.

Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ most recent market report, showcasing notable pricing trends and market share disparities across therapeutic areas.