Sandoz Group AG

Novartis' Scemblix (asciminib) approved by EC for Ph+ CML-CP treatment in adults previously treated with ≥2 TKIs, based on phase III ASCEMBL study showing higher response and lower discontinuation rates vs. Bosulif. Scemblix, a STAMP inhibitor, also FDA-approved, strengthens Novartis' oncology portfolio amid strategic focus on core pharma and therapeutic areas.

Novartis AG announces spin-off of Sandoz unit, aiming to form Europe's largest generic and biosimilar drug company. This decision follows a strategic review initiated in October, addressing shareholder concerns over Sandoz's performance.

The EU and US show similar biosimilar distribution trends, with the EU having a broader portfolio. Biosimilars are most developed for inflammatory diseases, immunology, and oncology due to high costs and prevalence. The EMA leads in biosimilar approvals, but the FDA's approval rate is faster. Regulatory strategies and patent protections significantly impact biosimilar market access, with the EU benefiting earlier than the US. The FDA's Biosimilar Action Plan aims to improve biosimilar development, approval, and market competition.

The pharmaceutical industry evolved from 19th-century roots, with companies like Merck and Pfizer pioneering drug manufacturing. Key developments include insulin, penicillin, and the contraceptive pill. The 21st century has seen advances in immunotherapy and gene therapy, alongside challenges like drug pricing and antibiotic resistance.

Recent developments in biosimilars include Biocon Biologics and Sandoz launching biosimilar competitors, legal settlements affecting biosimilar launches, and legislative efforts to increase biosimilar access. Key events involve adalimumab, ustekinumab, and aflibercept biosimilars, with companies like Amgen, Johnson & Johnson, and Regeneron at the center of legal and market activities.