Last week’s round-up, 04 – 08 November 2019

By Tessa Fiorini-Cohen and Marthese Mifsud


IPEC Continues to Encourage China to Align with Global Science-Based Excipient Standards

08 November 2019

Global excipient manufacturers are continuing to push the Chinese Pharmacopoeia to align with other pharmacopoeias.

Manufacturers are working through the International Pharmaceutical Excipients Council (IPEC), which is closely monitoring changes to requirements for drug application filings and excipient registration. IPEC is actively commenting on draft documents in the limited time-frames provided and encouraging the Chinese Pharmacopoeia to introduce science-based changes and bring monographs in line with those of global pharmacopoeias:


Biosimilar biologic drugs in Canada: Fact Sheet

07 November 2019

Health Canada has recently revised its fact sheet on biosimilars.

The fact sheet details a variety of information related to regulation of biosimilars in Canada, including: information requirements for initial authorisation, authorising indications, immunogenicity assessments, and safety monitoring post-authorisation.

As part of this update, further information has been included on interchangeability and switching. Naming conventions are also detailed, reflecting Health Canada’s decision earlier this year to change related practice:


Evolution of the EU Biosimilar Framework: Past and Future

06 November 2019

Biosimilar comparability is the focus of a recent research article, which reviews the extent of clinical confirmation needed in addition to analytical and functional data.

Case studies are presented based on a review of European Public Assessment Reports published between July 2012 and July 2019. These illustrate how components of a comparability exercise interrelate, and how to weigh conflicting results obtained from different parts of the exercise. The authors note that the pharmacokinetic study is emerging as “a major gatekeeper in the clinical biosimilarity exercise”, with all results needing to be fully justified before further clinical data can be deemed acceptable. Also noted is that the experience acquired with each biological product class has paved the way towards reduction of clinical data requirements and is expected to continue doing so:


FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications

05 November 2019

The FDA is working on creating a new system called KASA (Knowledge-aided Assessment & Structured Application), which is intended to modernize the quality assessment of regulatory drug applications.

A related review has recently been released, explaining its current state, related expectations and anticipated benefits. The KASA system is designed to capture and manage knowledge during the lifecycle of a drug product, establish rules and algorithms for risk assessment and related control, perform computer-aided analysis of applications, and provide a structured assessment that minimises text-based narratives.

It is expected that, when fully developed and implemented, KASA “will enrich the effectiveness, efficiency, and consistency of regulatory quality oversight through lifecycle management of products and facilities, and information sharing in a standardised and structured format”:


FDA Unveils New Tables for Submitting Bioanalytical Methods

04 November 2019

The FDA has released new templates that sponsors can use to submit summaries of bioanalytical methods used for pharmacokinetic assessments.

The templates can be used for new drug applications (NDAs) and biologics license applications (BLAs). Three different tables have been released: ‘Bioanalytical Method Life Cycle Information’, ’Summary Method Performance’ and ‘Summary of Method Modifications and Cross-Validation Results’. The FDA has recommended that the tables are included as an appendix in the Summary of Biopharmaceutics located in eCTD 2.7.1:


Image: Syringe and Vaccine, CC BY2.0

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