Another Biosimilar to Eylea Approved, But Not Launched

On Oct. 2, 2025, the US Food and Drug Administration (FDA) approved Celltrion’s Eydenzelt^® (aflibercept-boav), a biosimilar to Eylea^® (aflibercept – Regeneron) injection, 2mg. Eydenzelt is indicated to treat neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR). Eylea is approved for one additional indication to treat retinopathy of prematurity (ROP). Aflibercept 2mg is injected intravitreally by an ophthalmic specialist in a sterile setting – usually once every month or once every two months. The recommended dosing regimen varies by indication. Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor that blocks the growth of new blood vessels and decreases the ability of fluid to pass through blood vessels in the eye. Eydenzelt is the sixth biosimilar to Eylea approved by the FDA. Others include Opuviz^™ (aflibercept-yszy – Samsung Bioepis/Biogen), Yesafili^™ (aflibercept-jbvf – Biocon Biologics), Ahzantive^™ (aflibercept-mrbb – Formycon AG/Klinge Biopharma) and Enzeevu^™ (aflibercept-abzv – Sandoz). Based on settlement agreements, Yesafili, Ahzantive and Enzeevu are expected to be available in the second half of next year. It’s unclear when Opuviz and Eydenzelt will be launched. In August 2023, Regeneron introduced an 8mg strength, Eylea^® HD injection, which can be given once every two months or every four months. This new formulation is patent protected until at least 2039. In 2024, US sales of Eylea 2mg were approximately $6 billion and Eylea HD US sales were about $1.2 billion. Here is the full prescribing information for Eydenzelt.

FDA Approves Lower-Dose Zoryve for Young Children with Atopic Dermatitis

On Oct. 6, 2025, the US FDA approved a new strength of Arcutis Biotherapeutics’ Zoryve^® (roflumilast) cream 0.05% for the topical treatment of mild to moderate atopic dermatitis in children aged two years to five years of age. Previously, Zoryve was approved as a 0.3% foam for plaque psoriasis in patients 12 years and older and for seborrheic dermatitis in those nine years and older. The 0.15% cream formulation treats atopic dermatitis in patients six years and older. The new 0.05% cream expands access to approximately 1.8 million children aged two years to five years who require topical therapy for atopic dermatitis. A steroid-free topical phosphodiesterase-4 (PDE4) inhibitor, Zoryve showed that 25.4% of children in phase III trials achieved validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) success, and 39.4% reached Eczema Area and Severity Index (EASI-75), with improvements seen as early as week one. The cream was safe and well tolerated, with long-term use showing continued efficacy and disease control. The recommended regimen is to apply once daily to the affected areas and rub in thoroughly. Launch of this dose is expected by the end of October 2025. Here is the prescribing information.

Generic to Endometrin Launched

On Sept. 30, 2025, Xiromed’s progesterone vaginal insert 100mg launched. It is a generic equivalent to Endometrin^® (progesterone vaginal insert – Ferring Pharmaceuticals), for the support of embryo implantation and early pregnancy in infertile women undergoing Assisted Reproductive Technology (ART) treatment. It was FDA approved on Sept. 19, 2025. The company will have 180 days of market exclusivity. Endometrin reported $50.1 million in annual US sales for the 12 months ending July 2025.

Clotic Approved for Fungal Otitis Externa

The FDA approved Laboratorios Salvat’s Clotic^® (clotrimazole) otic solution on Sept. 26, 2025, for the treatment of fungal otitis externa (otomycosis/fungal ear infection) caused by Aspergillus and Candida species in adults 18 years and older with intact tympanic membranes. Clotic is the first FDA-approved therapy specifically indicated for fungal ear infections. Treatment options have traditionally included antifungal solutions or creams, such as off-label topical clotrimazole, as well as general antiseptics like acetic acid or boric acid. Approval was supported by two randomized, placebo-controlled phase III trials demonstrating therapeutic cure rates of 58.5% and 78.7% with Clotic versus 27.8% and 22.9% with placebo. Adverse reactions were rare, with isolated reports of application site pain, tinnitus and paresthesia. The recommended regimen is one single-dose vial instilled into the affected ear canal twice daily for 14 days. Clotic is contraindicated in patients with perforated tympanic membranes. Launch timing and pricing have not been disclosed. Full prescribing information is here.

Libtayo’s CSCC Indication Expanded to Include Adjuvant Treatment

On Oct. 8, 2025, the FDA approved Regeneron’s Libtayo^® (cemiplimab-rwlc) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation. Initially approved in 2018 for the treatment of metastatic or locally advanced CSCC in patients who are not candidates for curative surgery or radiation, Libtayo is already established as the standard of care in advanced CSCC. Approval was based on the phase III C-POST trial, which demonstrated a 68% significant reduction in the risk of disease recurrence or death compared to placebo. A programmed cell death protein-1 (PD-1) receptor inhibitor, Libtayo is given intravenously (IV) at 350mg every three weeks for 12 weeks, followed by 700mg every six weeks or continued at 350mg every three weeks for up to 48 weeks. Here is the updated prescribing information.

Lasix ONYU Approved

On Oct. 7, 2025, the FDA approved SQ Innovation’s Lasix^® ONYU (furosemide injection, 80mg/2.67mL) for the treatment of edema due to fluid overload in adult patients who have chronic heart failure. Heart failure affects 6.7 million Americans and is the leading cause of hospitalizations for individuals older than 65 years of age. This drug-device combination delivers subcutaneous furosemide via a wearable Infusor, enabling at-home therapy without clinical supervision. The Infusor includes a reusable electromechanical unit and a disposable cartridge system that delivers 80mg of furosemide over five hours. It can be used for 48 single dose prefilled cartridges, and the sterile plastic rechargeable unit can be discarded after use. The device adheres topically to a clean, hairless area of the abdomen and delivers the recommended dose of 30mg over the first hour, followed by 12.5mg per hour over the next four hours.  Use is limited to once or twice daily and patients should be transitioned to oral diuretics when feasible. Clinical studies demonstrated complete bioavailability and comparable diuretic and natriuretic responses compared to IV bolus administration, with a more tempered effect. The most common adverse reactions include infusion site reactions. Lasix ONYU will be available this quarter at participating medical facilities and affiliated retail pharmacies. Here is the updated prescribing information.

Recall

Gamunex-C Recalled

Grifols Therapeutics LLC issued a voluntary withdrawal of two lots of Gamunex-C^® (immune globulin injection [human], 10%) on Sept. 30, 2025, following a rise in reported hypersensitivity reactions associated with the affected vials. This marks the fourth such withdrawal in 2025, with previous actions taken on Feb. 19, Mar. 21 and Aug. 8, 2025, for the same safety concern. Gamunex-C is indicated for the treatment of primary humoral immunodeficiency (PI) in patients aged two years and older, idiopathic thrombocytopenic purpura (ITP) in both pediatric and adult populations and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. While hypersensitivity and anaphylactic reactions are already noted in the product’s prescribing information under warnings and precautions, the withdrawn lots may carry an elevated risk for these adverse events.