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 shelf life.
Failure to Use Orthogonal Methods: Relying on a single analytical technique can lead to incomplete impurity characterization. The FDA recommends using orthogonal methods (multiple methods with different separation principles) to ensure accuracy.
Uncharacterized Impurities: Impurities identified by Relative Retention Times (RRTs) must be fully characterized to determine their structure and potential impact.
Relaxed Impurity Limits: The FDA advises against setting impurity limits more relaxed than those observed in the RLD, as it could compromise the drug’s quality.
Excessive Aggregation: Higher levels of aggregates in the generic product, compared to the RLD, require thorough investigation to identify the root cause and implement improvements.
Conclusion
The approval process for generic peptide drugs, such as Teriparatide, involves stringent quality-related review considerations, including peptide characterization, impurity profiling, and immunogenicity risk mitigation. By adhering to FDA guidance and addressing common deficiencies, manufacturers can develop high-quality generic versions of peptide drugs that meet therapeutic equivalence standards while offering a safe, cost-effective alternative to brand-name medications.
Read also:
- Key Steps to Minimize the Chances of Getting a RTR from FDA
- A Comprehensive Comparison between ANDA (Generics) and Biosimilars
Resource Person: Shubham Sonu