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2024 saw key FDA approvals for rheumatology biosimilars, including high-concentration adalimumab and tocilizumab biosimilars, enhancing treatment options for autoimmune diseases. New evidence supports biosimilar-to-biosimilar switching safety. Samsung Bioepis’ Pyzchiva and Fresenius Kabi’s Tyenne approvals mark significant advancements in affordable autoimmune treatments.

FDA-approved biosimilars for IBD and inflammatory diseases, launching in 2025, aim to improve access, reduce costs, and expand treatment options.

FDA approvals include berdazimer gel for molluscum contagiosum, dupilumab for atopic dermatitis, DermaSensor for skin cancer detection, lifileucel for advanced melanoma, adalimumab biosimilar Simlandi, LUT014 for EGFRI-induced acneiform rash, Juvéderm for temple hollowing, spesolimab for pustular psoriasis, Stelara biosimilar Selarsdi, Cyltezo for various indications, tirbanibulin for actinic keratosis, tralokinumab for atopic dermatitis, sofpironium for hyperhidrosis, RhodoLED XL Lamp for actinic keratosis, roflumilast for atopic dermatitis, deuruxolitinib for alopecia areata, nemolizumab for prurigo nodularis, Candela's Matrix for facial wrinkles, lebrikizumab for atopic dermatitis, bimekizumab for psoriatic arthritis, delgocitinib for chronic hand eczema, ustekinumab biosimilar Otulfi, Accure Laser System for acne, and minocycline for rosacea.

Optum Rx prefers Amgen’s Amjevita over Sandoz’s Hyrimoz and Cyltezo on its 2025 commercial formularies, aiming to reduce costs and improve affordability. Humira remains on the formulary but with stricter controls. Biosimilars, including Humira’s, have struggled with adoption despite cost savings potential. Optum Rx also adds and removes various oncology and CNS medications for 2025.

Optum Rx prefers Amgen’s Amjevita over Sandoz’s Hyrimoz and Cyltezo on its 2025 commercial formularies, aiming to reduce costs and improve affordability. Humira remains on the formulary but is subject to prior authorization. Biosimilars have struggled with low adoption despite cost advantages, but large PBMs like CVS Health are shifting towards biosimilars. Optum Rx also adds and removes various oncology and CNS medications from its 2025 formulary.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

Skyrizi surpasses Humira in sales, causing concerns for adalimumab biosimilar market growth. Despite biosimilars capturing 22% market share by Oct 2024, Skyrizi's rise and product hopping complicate biosimilar sustainability. Clinical trials show Skyrizi's superior efficacy in psoriasis treatment, and policy reforms are advocated to enhance biosimilar access and competition.

Adalimumab biosimilars' market share rose from 2% to 22% in early 2024, driven by private label brands. The FDA approved 61 biosimilars across 17 molecules, with 41 launched in the US. Biosimilars' average sales prices decreased by 53% over 5 years. Major PBMs like CVS Caremark and Evernorth are adding biosimilars to formularies. Adalimumab biosimilars offer multiple pricing options, with some at 85-86% less than Humira. Biosimilars saved payers $1.6 PMPM, with potential for further growth.

Express Scripts, part of Cigna's Evernorth, plans to add three biosimilars to its National Preferred Formulary, including Sandoz's Hyrimoz and Adalimumab-adaz, and Boehringer Ingelheim's Cyltezo. These FDA-approved biosimilars offer cost-effective, clinically effective alternatives to HUMIRA for inflammatory conditions, aiming to reduce drug spending and increase treatment access. This move reflects Cigna's strategy to generate cost savings and potentially boost pharmacy revenues, with pharmacy revenues contributing 71.2% to Cigna's 2022 revenues.

Celltrion seeks FDA approval for its adalimumab biosimilar Yuflyma's interchangeability with Humira, aiming for a 2023 launch. Formycon reports positive phase 3 trial results for its ustekinumab biosimilar FYB202, comparable to Stelara in treating psoriasis, highlighting progress in biosimilar development.