Regeneron Pharmaceuticals

Biotechnology Market to grow at 13.9% CAGR from 2024-2031, driven by health, agriculture, and industrial applications. Valued at USD 1.21 Trillion in 2022, it is expected to reach USD 3.90 Trillion by 2031.

Samsung Bioepis receives European approval for ophthalmic biosimilar Opuviz (aflibercept), expanding its eye disease treatment portfolio. This marks the company's ninth product approval in Europe.

Fanaroff: Research grants from American Heart Association and National Institutes of Health; consulting fees from Abbott Laboratories. Vora: Consulting fees from Medtronic. Mehran: Institutional research grants from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi Sankyo, Medtronic, Novartis, OrbusNeich; consulting fees from Boston Scientific, Abbott Vascular, Medscape, Siemens Medical Solutions, Roivant Sciences Inc, Sanofi; consulting (no fees) for Regeneron Pharmaceuticals Inc; institutional consulting fees from Abbott Vascular, Spectranetics/Phillips/Volcano Corporation, Bristol Myers Squibb, Novartis, Watermark Research; Executive committee member for Janssen Pharmaceuticals and Bristol Myers Squibb; <1% equity in Claret Medical and Elixir Medical. Granger: Research grants from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Armetheon, AstraZeneca, US Food and Drug Administration, GlaxoSmithKline, The Medicines Company, Medtronic Foundation, Medtronic Inc, Novartis; consulting fees from Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Abbvie, Armetheon, AstraZeneca, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, The Medicines Company, National Institutes of Health, Novartis, Sirtex, Verseon, Apple, Medscape, LLC, Merck, Novo Nordisk, Roche Diagnostics, Rho Pharmaceuticals. Goodman: Research grant support and/or speaker/consulting honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo, Eli Lilly, Esperion, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Novo Nordisk A/C, Pfizer, Regeneron, Sanofi, Servier, Tenax Therapeutics, Heart and Stroke Foundation of Ontario/University of Toronto, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Duke Clinical Research Institute, PERFUSE. Aronson: Employee of Bristol Myers Squibb. Windecker: Institutional research and educational grants from Abbott, Amgen, Bayer, BMS, CSL Behring, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Polares, Sinomed. Alexander: Research grants from Bristol Myers Squibb, Boehringer Ingelheim, AstraZeneca, CryoLife, CSL Behring, US Food and Drug Administration, National Institutes of Health, Sanofi, VoluMetrix; consulting fees from Pfizer, Bristol Myers Squibb, AbbVie Pharmaceuticals, CSL Behring, Novo Nordisk, Portola Pharmaceuticals, Quantum Genomics, Teikoku Pharmaceuticals, VA Cooperative Studies, Zafgen. Lopes: Research grants from Bristol Myers Squibb, Pfizer, Amgen, Inc, GlaxoSmithKline, Medtronic PLC, Sanofi Aventis; consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer AG. The other authors report no conflicts.

Samsung Bioepis obtains European Commission marketing authorization for Opuviz, a biosimilar of Eylea, for treating ophthalmic diseases like wet age-related macular degeneration. This marks the company's ninth approval in Europe and second ophthalmic treatment, following Byooviz. Opuviz also received U.S. marketing authorization in May and Korean approval in February, sold through Samil Pharmaceutical.

Samsung Bioepis obtains European Commission approval for its biosimilar 'OfubizTM' for treating ophthalmic diseases, marking its second treatment in this field and ninth biosimilar approval in Europe.

Intellia Therapeutics reports early-stage data indicating its gene editing treatment, NTLA-2001, may stabilize or improve outcomes for ATTR-CM patients, showing a median improvement in the six-minute walk test and 92% maintaining or improving NYHA class. The treatment uses CRISPR to reduce TTR production, with a 90% mean reduction observed. Intellia is now in Phase III trials for NTLA-2001, with potential revenue of $1.2bn by 2030.

FDA accepts Sanofi and Regeneron's resubmitted sBLA for Dupixent in chronic spontaneous urticaria, targeting 18 April 2025 decision. Dupixent, inhibiting IL-4 and IL-13 pathways, showed significant itch and urticaria reduction in LIBERTY-CUPID Phase 3 studies. Safety consistent with established profile; common adverse events include injection site reactions and COVID-19 infections. Dupixent approved for CSU in Japan and UAE, under review in EU, and has broader approvals for various inflammatory conditions.

Intellia Therapeutics announced positive Phase 1 trial data for nex-z in ATTR amyloidosis, showing rapid, deep, and durable serum TTR reduction, disease stabilization or improvement, and favorable safety profile. Data presented at the 2024 AHA Scientific Sessions and published in the New England Journal of Medicine.

FDA reviews Dupixent (dupilumab) sBLA for chronic spontaneous urticaria (CSU) in adults and patients aged 12+ not controlled by H1 antihistamines, with a decision target date of April 18, 2025. LIBERTY-CUPID phase 3 studies support the application, showing Dupixent significantly reduces itch and urticaria activity. Dupixent is approved for CSU in Japan and UAE, under review in EU, and has been approved in over 60 countries for various conditions.

EMA approves Ronapreve (Roche) and Regkirona (Celltrion) for treating Covid-19 in patients not needing oxygen, pending EU Commission approval. Both drugs show favorable safety profiles.