Something Happening at USP for Biologics?

Representatives from a majority of the pharmacopeia’s expert panels are in Seattle, as are a few FDA officials, and industry members from around the world–some 30 countries are represented in fact. Various new approaches by USP are aiming to help industry better understand, develop, test, and manufacture biological products, including biosimilars.

Among the presentations and discussions being had, here a few summary points:

Fingerprinting, or super characterization, of biologics may or may not work for biotech. Figuring out what fraction of potential attributes of a certain product, and which are meaningful, is more crucial in today’s pharma manufacturing and regulatory environment. Along these lines, critical quality attributes (CQAs) are becoming more and more important as QbD approaches for biologics gain traction. For those interested in real time release testing or getting rid of some end product tests, unfortunately, it won’t be as easy for biologics as it is for the small molecule sector.

USP’s new horizontal approach to developing standards is taking shape. With the goal of developing CQAs for certain product classes, such as mAbs or peptides, the pharmacopeia is in the progress of drafting two new mAb chapters focusing on CQAs, tests, and methods. Binding chapter <129> will inclue a list of CQAs for recombinant therapeutic mAbs that can help assure their quality as well as test details to measure these attributes, and ultimately, limits. Informational chapter <1260> will provide more method details and best practices. USP is aiming to make the chapters flexible but setting limits will require a great deal of collaboration and compromise. Expect to see a public draft of each new chapter mid-year 2012.

It’s clear from the vibe at the conference that industry is eager to get moving on biosimilars, as well as innovator biologics, but many questions and challenges remain, especially on the regulatory front. With the Biologic Price Competition and Innovation Act still awaiting implementation and FDA guidance, industry seems hesitant to submit any applications–in fact no applications have been submitted to date for the 351 (k) biosimilar pathway. Some noted that FDA needs to move quickly to answer key questions so that innovation–and more importantly–patient access to drugs–can move forward.