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Int J Mol Sci 2022;23:9839

2 Oligopeptides & Tissue Repair (PubMed)Review of copper-binding peptides in wound healing and regenerative signalling

Phase 3: Clinical Program (Years 4-6) The FDA expects biosimilar aBLAs to include at minimum a Phase 1 pharmacokinetic/pharmacodynamic study in healthy volunteers (or patients if the product is too toxic for healthy volunteers) and, in most cases, a comparative efficacy study in the most sensitive indication