Regulatory Focus™ > News Articles > As Biosimilar Problems Emerge, EMA Looks to Create Quality Comparability Guideline

As Biosimilar Problems Emerge, EMA Looks to Create Quality Comparability Guideline

Posted 01 July 2013 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) has released a new concept paper calling for the development of a new framework to help solve one of the most difficult challenges associated with the development of biosimilar and biological products: ensuring that the quality of the biological product meets intended standards at all times during the development process.

The concept paper, released on 28 June 2013, explains that EMA has received several requests in recent years regarding the adequacy of data meant to compare the quality of two products, such as an innovative biological product and a follow-on biologic, otherwise known as a biosimilar product. If a biosimilar product is of insufficient quality relative to the reference product, it could be rejected by regulators.

Similarly, EMA said it has received other requests regarding the quality attributes of biological drug compounds once scale-up and post approval changes (SUPAC) occur. The question in that case: How similar does the post-approval quality of a biological product need to be relative to the version seen and approved by regulators? Are minor differences permitted to account for the challenges of scale or consistency between batches?

Regulators note that several methodological approaches of comparability have been proposed to date, "mostly based on information on batch-to-batch variability."

"The plurality of candidates of critical quality attributes within specific developments, as well as the usually low number of drug batches available had been identified as the most limiting factors, rendering the use of statistical routines usually performed on basis of clinical patient-data inappropriate most of the time," EMA explained. "Despite these limitations, it seems important to identify and discuss methods which may be adequate to serve for comparative purposes."

Accordingly, EMA is calling for the creation of a Reflection Paper (RP), a sort of policy foundation that lays out the basis for the development of a future guideline for industry. According to EMA, the RP would primarily be assessing the two problems listed above, as well as potential statistical methods to identify critical quality attributes, statistical comparison methods and batch production sizes.

EMA added that it believes the primary benefit of the RP will be to biosimilar development, but that it could also stand to benefit other scenarios in which comparative evaluation is useful, such as analyzing in vitro assays or small-molecule chemical drugs.

The timeline for the RP puts final publication of a guideline sometime in 2015.


EMA: Draft concept paper on the need for a reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development


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