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What Biosimilar Launch Timing Actually Depends On in a CIP-Heavy Patent Landscape Biosimilar launch timing in a CIP-heavy patent landscape is determined by three factors operating in sequence: the settlement negotiations between the innovator and the biosimilar developer, the results of any litigation on patents the parties cannot resolve by agreement, and the regulatory exclusivity periods 12 years for reference biologics under the BPCIA that run independently of patent status
The group lawsuit representing people harmed by Mounjaro and other GLP-1 drugs has grown by 486 cases between August and September of 2025
Diabetologia 66, 17651779
Rigorous, long-term prospective trials in asymptomatic, high-risk populations such as individuals with type 2 diabetes, obesity, or APOE4 carrier status are required to definitively validate or refute this hypothesis
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