ABBVIE

A report by the Access to Medicine Foundation examines how 20 major pharmaceutical companies are addressing patient access in low- and middle-income countries (LMICs), highlighting progress and areas needing improvement. The report identifies 42 different approaches to measuring patient reach, with 19 companies actively tracking this, but no industry-wide consensus. It calls for clearer, more actionable commitments to ensure lifesaving products reach underserved populations, emphasizing the need for collaboration and refining measurement methods to address health inequities.

Summit Therapeutics' experimental drug outperformed Merck's Keytruda in non-small cell lung cancer, led by iconoclastic figure Bob Duggan, a billionaire with no drug industry experience.

AI revolutionizes drug discovery by reducing time, cost, and improving success rates, exemplified by NImmune's TITAN-X platform. TITAN-X accelerates development of novel therapeutics like Omilancor and NIM-1324, validated by AbbVie's acquisition of Landos Biopharma. AI enhances precision medicine, not replacing human ingenuity.

The North America CMO and CDMO biotechnology market is robust, segmented by applications like oncology, cardiology, immunology, neurology, and metabolic diseases. Key manufacturers include Patheon, Catalent, Samsung Biologics, and Lonza. The market is driven by technological advancements and growing demand for automation, with a promising future for innovation and growth.

The Global Monoclonal Antibodies Market is projected to grow from USD 279.8 billion in 2024 to USD 804.7 billion by 2033, at a CAGR of 12.5%. North America is expected to dominate with a 47.5% share in 2024, driven by strong healthcare infrastructure and high R&D investments. Oncology is projected to lead the application segment with a 46.2% share. Major companies include Roche, Novartis, Johnson & Johnson, Pfizer, and Merck.

Nivolumab plus gemcitabine/cisplatin chemotherapy significantly improved response rates, overall survival, and progression-free survival in patients with lymph node–only metastatic urothelial carcinoma, according to a post hoc analysis of the CheckMate 901 trial presented at the 2024 ASCO Annual Meeting.

Despite declining use of Sanofi/Regeneron’s Dupixent due to competition from LEO’s Adbry, Pfizer’s Cibinqo, and AbbVie’s Rinvoq, the overall population receiving advanced treatments for atopic dermatitis is rising, according to Spherix Global Insights. Dermatologists estimate that two-fifths of adult atopic dermatitis patients now receive advanced systemic treatments, highlighting the demand for effective AD treatments. The potential approvals of Galderma’s nemolizumab and Eli Lilly’s lebrikizumab could further shift physician preferences, with nemolizumab expected to gain more adoption than lebrikizumab.

Global Monoclonal Antibodies Market to reach USD 804.7 billion by 2033, growing at a CAGR of 12.5% from USD 279.8 billion in 2024. Dominated by North America, human-derived antibodies, and oncology applications, with key players including Roche, Novartis, and Johnson & Johnson.

Post-approval changes are categorized into three classes: annual record reporting for minor modifications, CBE-30 supplements for moderate changes, and PAS for significant changes. The FDA introduced a document in July 2024 to clarify biosimilar post-approval modifications, emphasizing thorough studies and comparability protocols. Changes to dosage form or strength require PAS, including comparability and CAA data. Biosimilars can change route of administration, formulation, and introduce new indications without filing as new drugs, supported by the potential passage of the S-150 Bill.

AbbVie to present new data on ADCs at ESMO 2024, including results from Phase 2 PICCOLO trial on mirvetuximab soravtansine for platinum-sensitive ovarian cancer and Phase 2 LUMINOSITY trial on telisotuzumab vedotin for advanced NSCLC. Also, new safety and efficacy data from Phase 1 study of ABBV-400 in pre-treated NSCLC and GEA patients.