Amgen, Inc.

Dong-A ST received FDA approval for Imuldosa, a Stelara biosimilar, amidst a crowded market of approved but unlaunched biosimilars. Stelara's sales are expected to decline post-2023 patent expiry, with biosimilars like Amgen's Wezlana and Samsung Bioepis's Pyzchiva set to launch in 2025. Stelara, an IL-12/IL-23 inhibitor, treats psoriatic arthritis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.

The FDA approved Imuldosa (ustekinumab-srlf), a biosimilar to Stelara, for treating autoimmune diseases. Stelara, a top-grossing biologic, generated $10.86 billion globally in 2023. Imuldosa is the fifth ustekinumab biosimilar approved in the US, developed by Dong-A ST and Meiji Seika Pharma, and will be commercialized by Intas Pharmaceuticals.

The FDA approved Imuldosa (ustekinumab-srlf), a biosimilar to Stelara, for treating plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Stelara, a top-grossing biologic, generated $10.86 billion globally in 2023. Imuldosa is the fifth ustekinumab biosimilar approved by the FDA, developed by Dong-A ST and Meiji Seika Pharma, and will be commercialized by Intas Pharmaceuticals.

Competition authorities are expanding their review of pharmaceutical deals, focusing on whether existing tools for identifying and remedying competition issues are sufficient. The Multilateral Pharmaceutical Merger Task Force explores new enforcement approaches, considering factors like innovation effects, conglomerate effects, and coordinated effects. Authorities in regions like the EU, US, and APAC assess theories of harm, market definitions, and legal standards, with remedies often involving divestitures to ensure market competition.

Regeneron, despite being a latecomer in cancer therapies, aims to leverage its packed pipeline to become a leader in the next wave of oncology treatments. Dr. Israel Lowy, senior vice president of translational and clinical sciences in oncology, highlights the company's focus on combinations like Libtayo and fianlimab, which could rival existing treatments like Opdualag and Keytruda. Regeneron's journey includes pioneering bispecific antibodies and facing early challenges, but with ongoing clinical trials and collaborations, the company seeks to establish itself as a major player in cancer therapy.

David Baker, Demis Hassabis, and John Jumper won the 2023 Nobel Prize in chemistry for computational protein design and AlphaFold development. Alnylam Pharmaceuticals seeks FDA approval for vutrisiran in another form of transthyretin amyloidosis. Johnson & Johnson terminated TAR-200 trial in bladder cancer. Gemma Biotherapeutics partners with Brazil's Fiocruz for rare disease gene therapies. AstraZeneca acquires a preclinical cholesterol-lowering drug from CPSC Pharmaceutical Group. Astellas invests in AviadoBio's experimental gene therapy for frontotemporal dementia.

Pharma incumbents partner with AI-driven startups to enhance drug discovery, leveraging AI models for protein structure and molecule binding. AI aids in predicting patient responses, designing inclusion criteria, optimizing doses, and supplementing placebo groups with simulations. A recent analysis of AI in FDA drug submissions highlights these applications, with the FDA establishing an AI Council to clarify regulatory approaches.

Formularies have become significant barriers to realizing biosimilars' cost-saving potential, with inconsistencies in placement and rebate structures complicating adoption. Despite lower-cost biosimilars entering the market, formulary contracts and behavioral psychology hinder quick adoption, leading to potential savings remaining uncaptured. Recent shifts by PBMs like CVS Health and Optum show slow progress towards biosimilar preference, but systemic changes are needed to fully leverage their benefits.

Blue Shield of California will offer Idacio, an adalimumab biosimilar, at 75% less than Humira. This collaboration with Fresenius Kabi and Evio Pharmacy Solutions aims to reduce costs and improve access to biosimilars, with nearly all patients paying $0 out of pocket starting January 1, 2025.