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The ongoing litigation, however, centers on more serious gastrointestinal injuries

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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

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Myopathy and Myalgia: The most common manifestation of statin toxicity is myopathy, characterized by muscle weakness, pain, and tenderness