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Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 9 lytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act (PHS Act) (8). The guidance also offers recommendations on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a pro- posed product submitted under section 351(k) of the PHS Act. Among an overview of the PHS Act and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), the guidance specifically dis- cusses expression systems, manufacturing pro- cesses, physicochemical properties, functional activities, target binding, impurities, reference products and standards, finished drug products, and stability. Considerations addressed for a com- parative analytical assessment include reference and biosimilar products and data analysis. The guidance is part of a series of documents to facilitate the implementation of the BPCI Act. Other guidance documents address scientific considerations, biosimilar development, clinical pharmacology data, labeling of biosimilars, and demonstrating interchangeability. Pharmacopeia updates FDA released draft guidance on July 10, 2019 that assists applicants in initiating revisions to an ex- isting monograph or the development of a new monograph under the United States Pharmaco- peial Convention–Pending Monography Process (USP–PMP) during FDA's evaluation of a drug substance master file or drug product application (9). Applicants of drug approvals must comply with USP National Formulary (NF) standards, if applicable. The guidance assists these applicants in using the USP–PMP to request a revision of compendial standards. In the past, if proposed specifications in a drug application appeared to not comply with the cur- rent USP monograph, FDA approval of the ap- plication would be delayed. Until the USP–PMP was established, there was no process for drug de- velopers to request changes to compendial stan- dards for products that were not yet approved by FDA. This draft guidance describes the process for the "revision of compendial standards that are harmonized with the approved quality and label- ing requirements for a drug product application," including how to initiate the USP–PMP process. USP announced on Aug. 3, 2019 that it is propos- ing a policy change to the inclusion of reporting thresholds in drug substance and drug product monographs (10). The proposal comes in response to FDA's recommendation that reporting thresh- olds should be addressed as part of application as- sessments based on product-specific factors and not be included in drug product monographs. USP is updating organic impurities testing in alignment with ICH Q3A/B-based limits for identification and reporting of organic impurities and degradation products in drug substances and drug products. These impurities tests currently include, in some cases, a reporting threshold con- sistent with ICH guidelines. USP stated in a press release that, "In addition to setting criteria for a peak to be included in the total impurities, the reporting threshold also aligns with the approach to verify the system sensitivity. Monographs with recently modernized or new impurity procedures