Sandoz Group AG

Tonix Pharmaceuticals submits NDA for TNX-102 SL, a non-opioid, centrally-acting analgesic for fibromyalgia, after two Phase 3 studies showed significant pain reduction. If approved, TNX-102 SL would be the first new drug for fibromyalgia in over 15 years.

FDA approves Imuldosa (ustekinumab-srlf), a biosimilar to Stelara, for treating psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis in both adults and pediatric patients. Imuldosa, initially developed as DMB-3115, demonstrated similar pharmacokinetic, safety, tolerability, and efficacy profiles to Stelara, adhering to FDA biosimilar guidance. This marks the fifth FDA approval for an ustekinumab product, with Imuldosa anticipated to launch in the first half of 2025.

Regeneron loses bid to block Amgen's Eylea biosimilar, plans appeal; Prime Therapeutics adds low-cost Humira biosimilars; FDA and EMA accept Alvotech's denosumab biosimilar for review.

UK High Court upheld patent EP 1 893 196 for enzalutamide, rejecting generics' claim of obviousness. The patent, owned by UC Regents and licensed to Astellas, covers the prostate cancer drug Xtandi. Parallel proceedings are pending in Europe.

Samsung Bioepis wins Asia-Pacific Company of the Year at 2024 Global Generics & Biosimilars Awards for the third consecutive year. The company achieved milestones in 2024, including approvals for biosimilars Pyzchiva and Epysqli, and a robust portfolio of 11 biosimilar products.

The FDA approved a single-dose, generic paclitaxel formulation for metastatic breast cancer, marking the first approval of an abbreviated new drug application to the reference product. Developed by Sandoz in partnership with Jiangsu Hengrui Pharmaceuticals, the lyophilized powder for injection consists of 100 mg of paclitaxel as albumin-bound particles. The agent is also indicated for non–small cell lung cancer and metastatic adenocarcinoma of the pancreas. The recommended dose for metastatic breast cancer is 260 mg/m2 over 30 minutes every 3 weeks, with precautions for neutrophil counts and hepatic impairment.

Sandoz launches first FDA-approved generic paclitaxel for metastatic breast cancer, a single-dose 100 mg vial for IV use, developed with Jiangsu Hengrui Pharmaceuticals. Indicated for patients with metastatic breast cancer after chemotherapy failure, it carries warnings of severe myelosuppression and requires monitoring for neutropenia.

Sandoz launches first FDA-approved generic paclitaxel for metastatic breast cancer, a single-dose 100 mg vial for IV use, expected to drive near-term growth in the US market.

Drug shortages impact 84% of generic drugs, costing hospitals $600 million annually and leading to higher prices. Factors include price deflation, GPO consolidation, and patent litigation. Policy changes are needed to ensure timely insurance coverage for generics, reform patent laws, and balance local and global supply chains.

Milan's IP court shake-up impacts proceedings; Italian Supreme Court's Bolar exemption interpretation affects pharma litigation. Trevisan & Cuonzo and Bird & Bird lead in patent disputes, with firms like Hogan Lovells and Simmons & Simmons also prominent. Italian IP boutiques maintain strong presence, often combining academic work with litigation.