Company

Regeneron

Trevogrumab. Muscle-sparing anti-obesity approach.

4 signals

Market access

Drug	Indication	Brazil	China	France	Germany	Italy	Japan	Korea	Spain	UK	US
Praluent alirocumab	CV risk reduction

View full market access tracker

Disease Area

Source

4 of 4 signals

Strategic Signal

EMA21 May 2026CHMP Positive Opinion● 4/10i

EMA: CHMP Positive Opinion: Vislyfa (ranibizumab)

CHMP issued a positive opinion for Vislyfa (ranibizumab, Lupin Europe) for neovascular age-related macular degeneration, visual impairment, and other retinopathies on May 21, 2026. This represents a new marketing authorization application following the biosimilar pathway for Lucentis (Roche/Novartis). Lupin gains entry into the established anti-VEGF ophthalmology market, joining existing biosimilars competing against originator Lucentis and next-generation Eylea (Regeneron/Bayer). The approval adds another biosimilar option in a market where treatment costs remain a significant access barrier across EU healthcare systems.

OtherLupin Roche Novartis Regeneron Bayer

Strategic Signal

PubMed16 Apr 2026European heart journal● 7/10i

PCSK9 inhibitor treatment and outcomes in patients with atherosclerotic cardiovascular disease but without prior ischaemic events: an observational study.

PCSK9 inhibitor monoclonal antibodies reduced major cardiovascular events by 31% versus standard care in people with atherosclerotic cardiovascular disease but without prior ischemic events. Real-world observational study using US claims data, 19,670 patients followed for 5 years with propensity score matching. This provides the first large-scale real-world evidence for PCSK9 inhibitors in primary prevention within high-risk ASCVD populations, extending beyond the clinical trial evidence that has driven current guidelines. The observational design limits causal inference compared to randomized controlled trials.

PCSK9CardiovascularReal-world evidenceAmgen Regeneron

Strategic Signal

EMA14 Apr 2026EC Decision — New Marketing Authorisation● 6/10i

EMA: EC Decision — New Marketing Authorisation — Pavblu (aflibercept)

The European Commission approved aflibercept (Pavblu, Amgen) for neovascular age-related macular degeneration, visual impairment from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization on April 14, 2026. This represents a new marketing authorization following CHMP positive opinion in January 2025. The approval establishes Amgen's entry into the competitive anti-VEGF ophthalmology market, challenging established players Regeneron/Bayer (Eylea) and Roche (Lucentis/Vabysmo) across multiple retinal indications.

OtherAmgen Regeneron Bayer Roche

Strategic Signal

PubMed1 Apr 2026Diabetes, obesity & metabolism● 6/10i

Impact of conventional lipid-lowering therapy on circulating levels of proprotein convertase subtilisin/kexin type 9: A systematic review and meta-analysis of randomised controlled trials.

Conventional lipid-lowering drugs increase plasma PCSK9 levels by 23.25 ng/mL across all major drug classes including statins, ezetimibe, and fibrates. Meta-analysis of 14 RCTs with 1,313 participants across multiple treatment arms. This provides the first comprehensive quantification of PCSK9 elevation across all conventional lipid therapies, confirming a mechanistic concern that has lacked systematic evidence. Subgroup analyses show variation by drug intensity and type, but the overall signal is consistent.

PCSK9CardiovascularDrug comparisonsRegeneron Sanofi Amgen