ABBVIE

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.

I-DXd (ifinatamab deruxtecan) showed clinically meaningful responses in pretreated extensive-stage SCLC patients, with a confirmed response rate of 26.1% at 8 mg/kg and 54.8% at 12 mg/kg. The 12 mg/kg dose was selected as optimal for further study.

2024 sees ongoing FTC scrutiny of life sciences transactions, including Novo's $16.5B Catalent acquisition and AbbVie's $8.7B Cerevel deal. The FTC challenges 'junk' patents in the FDA's Orange Book and releases an interim report on PBMs. The EU Commission opens its first abuse-of-dominance probe related to Zoetis shelving a veterinary therapy. Despite regulatory focus, deals in radiopharmaceuticals and metabolic diseases proceed without notable investigations.

Dupixent's dominance in the atopic dermatitis market is waning due to new treatments like Adbry, Cibinqo, and Rinvoq. Dermatologists estimate advanced systemic treatments now serve two-fifths of adult AD patients, highlighting the need for new options. Efficacy attributes like itch reduction and mechanism of action are key differentiators, with nemolizumab and lebrikizumab expected to further shift preferences away from Dupixent.

Dupixent's dominance in atopic dermatitis treatment is diminishing with the rise of competitors like Adbry, Cibinqo, and Rinvoq. Dermatologists anticipate adopting nemolizumab and lebrikizumab, further challenging Dupixent's market share.

Pivekimab sunirine's US revenue forecasted at $21 mn by 2038, with a risk-adjusted NPV model (rNPV) considering phase transition success rates and likelihood of approval. IMGN-632, under development for CD123-positive hematologic malignancies, is administered intravenously. AbbVie, a biopharmaceutical company, reported FY2023 revenues of $54,318 mn, with a net margin of 9%.