Generic Drugs
Teriparatide Injection’s Generic Approval and FDA Quality-Related Review
Introduction to Teriparatide and its Generic Approval Teriparatide, a peptide-based drug consisting of 34 amino acids with a molecular weight of 4117.8 daltons, is primarily indicated for treating osteoporosis. Its formulation comes as a clear solution in a multi-dose injector pen for subcutaneous injection. Teriparatide is administered daily in a ... Read More
Addressing Immunogenicity Concerns and Impurity Profiling for Peptide Drugs
Immunogenicity, or the potential to trigger immune responses, is a critical concern for peptide drugs like Teriparatide. Impurities, aggregates, or contaminants in peptide-based generics could lead to unwanted immune reactions. Thus, the FDA recommends evaluating both the innate and adaptive immune responses when developing a generic peptide. Innate Immune Response: ... Read More