Fresenius Kabi Reaches Agreement with J&J over Stelara Biosimilar

Fresenius Kabi and Formycon have reached a settlement with Johnson & Johnson concerning FYB202, a proposed ustekinumab biosimilar to Stelara, which is approved to treat psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The settlement allows Fresenius Kabi and Formycon to launch their product, once approved by the FDA, in the United States no later than April 15, 2025.

FYB202 is a human monoclonal antibody that targets the cytokines interleukin-12 and interleukin 23 for treatment of immune-mediated disorders. Fresenius Kabi and Formycon are on track to submit a biologics license application later this year, the companies said in a press release. In February 2023, Fresenius Kabi announced a global license agreement with Formycon to commercialize FYB202 in key global markets.

This follows the settlements J&J reached in May 2023 with Amgen, which will allow Amgen’s ustekinumab biosimilar to launch no later than Jan. 1, 2025; and with Alvotech/Teva’s biosimilar, AVT04, which allow the companies to launch no later than Feb. 21, 2025. AVT04 is waiting FDA approval.

In other generic news:

Dr. Reddy Launches Diabetes Generic

Dr. Reddy's Laboratories has launched Saxagliptin and Metformin Hydrochloride Extended-Release Tablets, a therapeutic equivalent generic version of AstraZeneca’s Kombiglyze XR, which is used to treat type 2 diabetes. Kombiglyze XR, however, has been discontinued for business reasons. Dr. Reddy’s product are supplied in a strength of 2.5 mg/1000 mg in bottle count of 60 and strengths of 5 mg/500 mg and 5 mg/1000 mg each in bottle counts of 30.

Amneal Receives Approval for Generics; Submits New Applications

Amneal Pharmaceuticals has launched its authorized generic for Xyrem 1 (sodium oxybate) oral solution developed by Jazz Pharmaceuticals. Sodium oxybate oral solution, 0.5 g/mL is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness in patients seven years of age and older with narcolepsy.

Amneal has FDA approvals for five complex generics products. Three recently approved products are injectables, including dexmedetomidine injection, which is currently on the U.S. FDA shortage product list. These include:

• Medroxyprogesterone acetate injectable suspension, 150mg/mL, a generic version of Depo-Provera, a contraceptive 
• Dexmedetomidine hydrochloride in 0.9% sodium chloride injection, 4 mcg/mL.a generic version of Precedex Injection, which is used for sedation when patients are intubated and mechanically ventilated
• Nelarabine injection, 250mg/50mL (5mg/mL) is a generic version of Arranon Injection, which is used to treat leukemia and lymphoma
• Dapsone 7.5% gel is a generic version of Aczone, which is used to treat acne
• Mometasone furoate nasal spray, 50 mcg is a generic over-the-counter version of Nasonex, which is used to treat symptoms of allergies and hay fever.

In addition, Amneal has submitted abbreviated new drug applications for three generic products: albuterol sulfate inhalation, bimatoprost ophthalmic solution, 0.01%, and propofol emulsion. Injectable propofol emulsion, the generic version of Diprivan, is an IV general anesthetic and sedation drug. Amneal plans to manufacture propofol emulsion internally by leveraging the company’s global injectables infrastructure.

Bimatoprost ophthalmic solution, the generic version of Lumigan, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Albuterol sulfate inhalation, the generic version of Proair HFA, is indicated for the treatment or prevention of bronchospasm related to exercise-induced or reversible obstructive airway disease.