EMA’s Biosimilar Quality Guideline Redraft Sharpens Focus on Target Profiles and Lifecycle Changes of Reference Product

The new draft of EMA’s biosimilars quality guideline includes a heightened focus on understanding the quality target product profile (QTPP) of the reference product and the changes that have occurred to the quality attributes over the reference product’s lifecycle.

Also apparent in the new draft is a shift in emphasis from the earlier 2006 version’s preoccupation with the active substance onto the comparability of the finished product as the final arbiter of patient relevance.

A firmer grounding of the guidance in the evolving quality-by-design (QbD) concepts and their product lifecycle implications better aligns the EMA guidance with FDA’s new biosimilars quality draft (IPQ “The News in Depth” Feb. 13, 2012) and the refinements in the approach that companies on the biosimilars frontline like Sandoz are making.

The development expectations in the new EMA draft are reframed in the QbD syntax and reflect the growing experience that the biotech community has gained in incorporating the concepts into their development and submission programs. EMA and FDA regulators have a better sense of what they need to see to understand and minimize the risks in biosimilars and have built that understanding into their biosimilars guidance.

The revised EMA draft biosimilars quality guideline has a six-month public comment period that ends November 30.

[An analysis of the changes to the EMA guideline and how it compares to the FDA version is provided for subscribers here.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (Jonathan@ipq.org).  For subscription/license information, click here.]

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