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Credit/Source: Maryam Daneshpour #biosimiliar #biotech #biopharma #pharmaceuticals To view or add a comment, sign in Biosimilars: FDA vs EMA Approvals Big news in biosimilars: the FDA has, for the first time, accepted a monoclonal antibody (mAb) biosimilar application without requiring clinical efficacy studies

However, this efficacy comes with the caveat of side effects, notably gastrointestinal discomfort, including burping, nausea, and abdominal pain

While the expiry of data exclusivity in January 2026 was anticipated, the earlier lapse of the semaglutide patent through non-payment of a small maintenance fee raised eyebrows

Consult a healthcare provider Always seek advice from medical professionals before taking peptides for health