FDA considers any polymer composed of 40 or fewer amino acids to be a peptide.
Peptides can occur naturally in the body or can be produced in a laboratory through chemical synthesis or recombinant DNA technology using other living systems (e.g., bacteria). For example, bradykinin (Image 1) is a peptide that is a naturally occurring hormone in the body and controls blood pressure while glatiramer acetate is a peptide drug product that is created in a laboratory and intended to treat multiple sclerosis. Peptide drug products play a significant role in providing necessary medications for the public, but the manufacture of peptide drug products presents unique challenges. Moreover, the manufacturing of generic peptide drug products that are equivalent to their brand name counterparts has been particularly challenging. Currently, there are approximately 100 peptide drug products marketed in the U.S., Europe, and Japan. Annual global sales for peptide drug products are estimated to be $15 billion to $20 billion.
The Scientific Challenge for Approval of Generic Peptide Drug Products
FDA has seen a rapid increase in the number of new drug applications submitted for peptide drug products. The availability of generic versions of these products will be critical to increasing public access to these important medications. However, ensuring the quality and equivalence between generic and brand name peptide drug products raises a number of challenges, and those challenges differ according to the type of peptide drug.
For peptide drug products with a specifically defined sequence of amino acids, the challenge has been with impurities that may be inadvertently introduced during the production process that may affect a proposed generic drug’s safety profile. Peptide-related impurities can be especially difficult to detect, analyze, and control because they usually have similar sequences to the drug itself…