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Current biosimilar development status (as of April 2026): At least 6 companies have filed Investigational New Drug (IND) applications for biosimilar semaglutide with the FDA Leading candidates: Sandoz (filed IND March 2024), Teva (filed IND August 2024), Biocon (filed IND November 2024) Earliest possible FDA approval: Q4 2027 for Sandoz if Phase 3 trials meet endpoints Manufacturing implications: Biosimilar manufacturers will need to build or contract fill-finish capacity (API production can use existing biologics facilities) Most biosimilar manufacturers are partnering with contract development and manufacturing organizations (CDMOs) rather than building dedicated facilities Expected biosimilar pricing: 30-50% below Wegovy list price based on insulin biosimilar precedent The patent thicket: Novo Nordisk holds 50+ patents covering semaglutide, including formulation patents, manufacturing process patents, and pen device patents Biosimilar manufacturers will need to design around device patents (likely using vial-and-syringe format initially) Patent litigation will likely delay first biosimilar launch by 12-24 months past initial FDA approval Prediction: The first biosimilar semaglutide will receive FDA approval in Q4 2027 but won't reach pharmacies until Q2 2028 due to patent litigation and manufacturing scale-up