Are the biologic development requirements different than the requirements for a new drug product?
Biological products are a subset of drugs; therefore both are regulated under provisions of the FDC Act. However, only biological products are licensed under section 351 of the PHS Act. (As previously noted, some therapeutic protein products are approved under section 505 of the FDC Act, not under the PHS Act.)
Following initial laboratory and animal testing that show that investigational use in humans is reasonably safe, biological products (like other drugs), can be studied in clinical trials in humans under an investigational new drug application (IND) in accordance with the regulations at 21 CFR 312. If the data generated by the studies demonstrate that the product is safe and effective for its intended use, the data are submitted as part of a marketing application. Whereas a new drug application (NDA) is used for drugs subject to the drug approval provisions of the FDC Act, a biologics license application (BLA) is required for biological products subject to licensure under the PHS Act. FDA form 356h is used for both NDA and BLA submissions. FDA approval to market a biologic is granted by issuance of a biologics license.
Are the biologic development requirements different than the requirements
for a new drug product?
Biological products are a subset of drugs; therefore both are regulated
under provisions of the FDC Act. However, only biological products are
licensed under section 351 of the PHS Act. (As previously noted, some
therapeutic protein products are approved under section 505 of the FDC Act, not under the PHS Act.)
Following initial laboratory and animal testing that show that
investigational use in humans is reasonably safe, biological products (like other drugs), can be studied in clinical trials in humans under an
investigational new drug application (IND) in accordance with the
regulations at 21 CFR 312. If the data generated by the studies demonstrate that the product is safe and effective for its intended use, the data are
submitted as part of a marketing application. Whereas a new drug
application (NDA) is used for drugs subject to the drug approval provisions of the FDC Act, a biologics license application (BLA) is required for
biological products subject to licensure under the PHS Act. FDA form 356h is used for both NDA and BLA submissions. FDA approval to market a biologic
is granted by issuance of a biologics license.