Fresenius Kabi

The BIOSECURE Act, aiming to restrict Chinese companies from US business, passed the House with bipartisan support. Industry experts discuss the potential impact on biotech supply chains, with concerns over reliance on Chinese partners for manufacturing and raw materials. Suggestions include diversifying to Europe and India, and the need for resilience and innovation in improving patient outcomes.

DelveInsight's 'Ankylosing Spondylitis Pipeline Insight, 2024' report details the clinical development scenario and growth prospects across the Ankylosing Spondylitis market, covering 20+ key companies and 20+ treatment therapies. The report includes insights on clinical trials, therapies, mechanism of action, route of administration, and developments, with a focus on emerging therapies like KIN-1901, Sonelokimab, QX 002N, SHR-1314, SHR0302, Jaktinib, and Apremilast. Key companies include Pfizer, UCB Biopharma, Fresenius Kabi, and Shanghai Henlius.

The global halal empty capsules market is projected to grow from USD 1.28 billion in 2024 to USD 2.16 billion by 2034, driven by increasing demand for halal-certified products and plant-based capsules. North America dominated the market in 2023, while Asia Pacific is expected to grow fastest. The gelatin segment led in 2023, but non-gelatin is projected to grow significantly. The pharmaceutical industry is the largest application segment, with the nutraceutical segment expected to grow rapidly. AI is enhancing drug manufacturing processes, and rising demand for dietary supplements and generic drugs is boosting market growth. Challenges include the lack of halal-certified raw materials and the costly certification process.

FDA accepts Organon's aBLA for HLX14, a Prolia®/Xgeva® biosimilar, and Teva's application for its Prolia® biosimilar TVB-009P. Litigations continue between Amgen and biosimilar developers Celltrion, Samsung Bioepis, and Fresenius Kabi. Sandoz's Jubbonti®/Wyost® was approved as interchangeable with Prolia®/Xgeva®.

Organon announced FDA acceptance of its aBLA for HLX14, a biosimilar of Amgen’s Prolia®/Xgeva® (denosumab), licensed from Shanghai Henlius Biotech. Teva also announced FDA and EMA acceptance of its Prolia® biosimilar TVB-009P. These join Celltrion, Fresenius Kabi, and Samsung Bioepis’s denosumab biosimilar applications awaiting FDA approval. Litigations between Amgen and Celltrion, Samsung Bioepis, and Fresenius Kabi are ongoing. Sandoz’s Jubbonti®/Wyost® (denosumab-bddz) was FDA-approved as interchangeable with Prolia®/Xgeva®, with a U.S. market entry date by May 31, 2025, or earlier under certain circumstances.

New ustekinumab biosimilar approvals for chronic inflammatory diseases, data supporting equivalent safety of etanercept and infliximab biosimilars, and significant cost savings with adalimumab biosimilar.

US drug shortages decreased to 277 in Sept 2024, with 50% lasting 2+ years. Key shortages include ADHD meds, pain treatments, chemotherapy drugs, insulin, and diabetes/weight loss meds. IV fluids added due to Hurricane Helene impacting Baxter's production.

FDA approves expanded dosage for actinic keratosis drug, fourth ustekinumab biosimilar Otulfi approved in US and EU, FDA clears Accure’s laser system for acne, 320 mg bimekizumab pre-filled syringe and autoinjector approved, Health Canada approves roflumilast foam for seborrheic dermatitis, long-term results for ESK-001 in psoriasis, 40-week efficacy and safety of oral povorcitinib for prurigo nodularis, significant proportion of AD patients maintain stable EASI with tralokinumab, patients switching from dupilumab to upadacitinib achieve higher treatment targets in AD, final ECZTEND study confirms long-term safety and efficacy of tralokinumab, benvitimod is safe and effective for palmoplantar pustulosis, UCB announces head-to-head trial comparing bimekizumab and risankizumab, additional study confirms benzene presence in benzoyl peroxide products, LEO Pharma launches delgocitinib for chronic hand eczema in Germany, Almirall completes decentralized approval for efinaconazole in Europe, analyzing efficacy and safety in diverse clinical trials for roflumilast, disparities in hidradenitis suppurativa for skin of color populations, new treatments enhance care for diverse psoriasis patients.

Teva and mAbxience announce a global licensing agreement for the development of an anti PD-1 oncology biosimilar, marking their second collaboration. mAbxience will lead development and production, while Teva will manage regulatory approvals and commercialization, aiming to provide cost-effective, high-quality biosimilar treatments globally.

The FDA approved an additional presentation of Alotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn), a biosimilar to Stelara (ustekinumab), for intravenous infusion. This approval aligns Selarsdi's label with Stelara's indications, including psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease. This marks the second biosimilar of Stelara approved by the FDA, following earlier approvals of Wezlana, Pyzchiva, and Otulfi.