Peptide 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
Common Deficiencies in ANDA Submissions for Peptide Drugs
The FDA highlights several common deficiencies observed in the review of peptide-based generic drugs, including Teriparatide: Impurity Profiles Not Up to Date: Manufacturers often submit impurity profiles based on products aged at release. The FDA recommends that profiles also include data from samples aged at the end of the proposed ... 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
Assessing Immunogenicity Risk of Peptides
Immunogenicity risk assessment is crucial in developing highly purified synthetic peptide drug products, especially when referencing recombinant DNA (rDNA)-origin biologics. The FDA’s Synthetic Peptide Guidance and Product-Specific Guidances (PSGs) provide a structured approach to evaluating these risks and ensuring generic peptide safety and efficacy. Key Takeaways from the Guidance & ... Read More