Omalizumab

Alvotech's AVT05, a biosimilar to Simponi (golimumab), has had its Marketing Authorization Application accepted by the European Medicines Agency, with approvals expected by Q4 2025. Alvotech and Advanz Pharma expanded their partnership in May 2023 to include AVT05 and other biosimilars. Positive clinical results for AVT05 were announced in April 2024 and November 2023.

EMA accepts Alvotech's MAA for AVT05, a biosimilar to Simponi®, expected to complete approvals by Q4 2025.

Alvotech and Advanz Pharma announce EMA acceptance of AVT05, a proposed biosimilar to Simponi® (golimumab), for marketing authorization, expected to be completed by Q4 2025.

Evommune, a California biotech, raised $115 million to advance its two chronic immune condition drugs, EVO756 and EVO301, through Phase 2 trials by 2026. EVO756, an oral treatment targeting mast cells, is in mid-stage testing for chronic skin hives, while EVO301, a fusion protein, aims to treat eczema. The funding, co-led by RA Capital Management and Sectoral Asset Management, positions Evommune for potential IPO.

Novartis Q3 2024 results: net sales +10% (cc, +9% USD), core operating income +20% (cc, +17% USD), driven by strong performance from Entresto, Cosentyx, Kisqali, Kesimpta, Pluvicto, and Leqvio. Operating income +123% (cc, +106% USD), net income +121% (cc, +111% USD), core EPS +20% (cc, +18% USD) to USD 2.06. Free cash flow USD 6.0 billion (+18% USD). Full-year 2024 guidance raised: net sales expected to grow low double-digit, core operating income high teens.

Effective Jan. 1, 2025, BCBSIL will review medical necessity for self-administered drugs like Fasenra, Tezspire, Nucala, and Xolair. If not medically necessary, they should be self-administered under the pharmacy benefit. Members currently treated under the medical benefit will be notified. Medical necessity decisions require documentation and may involve BlueApprovR. Always check eligibility and benefits for each member.

76% of FDA-approved mAbs have high concentration formulations, necessitated by subcutaneous delivery. High-concentration biologics (over 100g/L) face challenges like increased viscosity and aggregate formation, requiring optimization of TFF parameters and new cassettes. Key biologics include Novartis’s Cosentyx, Genentech/Novartis’s Xolair, and Sanofi/Regeneron’s Dupixent. Selecting the right membrane for filtration is crucial, aiming for high throughput and cost reduction.

A qualitative study with 60 allergists revealed enthusiasm for biologics' potential in treating food allergies, but concerns about novelty, cost, and overuse. Themes included perceived benefits, ideal uses, concerns, and biologics as the future of treatment. Omalizumab's FDA approval has arrived, but allergists' perceptions of biologics' risks and benefits remain largely unknown.

The 'Chronic Urticaria: Competitive Landscape' report by ResearchAndMarkets.com details the current and future therapeutic market, highlighting key players like Regeneron/Sanofi (Dupixent) and Genentech/Novartis (Xolair). With over 60 million diagnosed cases in 16 countries, the report covers 42 pipeline molecules, including 3 in Phase III and 17 in Phase II. The US leads in trial sites for chronic urticaria, followed by China. The report also analyzes acquisition deals and provides strategic insights for market players.