Genentech sought regulatory approval for the clinical indication of macular degeneration treatment only for ranibizumab, not for bevacizumab.
Notes on verification
Corroborated by US health policy literature, ophthalmology industry interviews, and EU/Italian/French antitrust regulatory records, all describing the same regulatory strategy independently across different jurisdictions and time periods. [tier=silver indep_score=0.574 clusters=5 claim_tier=notable | framework convergence=partial (upstreams: US FDA approval records, Italian Competition Authority (AGCM) decision I760, French Competition Authority decision, EMA marketing authorization records) — publishers independent, evidence may not be | kind=empirical eligibility=high]
Sources
- Procedura di infrazione da parte dell'Autorità Antitrust (seed:health_and_medicine)
- https://www.raps.org/resource/french-regulator-and-roche-trade-blows-over-off-la.html (corroboration)
- https://pmc.ncbi.nlm.nih.gov/articles/PMC4137040/ (corroboration)
- https://www.centerforbiosimilars.com/view/an-interview-with-the-american-academy-of-ophthalmology-about-its-bevacizumab-concerns (corroboration)
- https://www.vbb.com/insights/corporate-commercial-regulatory/french-competition-authority-genentech-novartis-and-roche-fined-eur-444-million-in-saga-involving-wet-age-related-macular-degeneration (corroboration)
- https://lawhealthtech.com/tag/antitrust/ (corroboration)