US: Industry groups support FDA’s latest biosimilar analytic assessment guidance

30-07-2019

US: Industry groups support FDA’s latest biosimilar analytic assessment guidance

(Source: RAPS 2019-07-31)

Industry groups representing pharmaceutical, biologic and biosimilar manufacturers say they support the US Food and Drug Administration’s (FDA) draft guidance on comparative analytical assessment and other quality-related considerations for developing biosimilars, though some sticking points remain.

The 28-page draft guidance revises the agency’s 2015 guidance on quality consideration for demonstrating biosimilarity and replaces a 2017 draft guidance on statistical approaches to evaluating biosimilarity that was withdrawn last year.

PhRMA and the Biotechnology Innovation Organization (BIO) say they support the draft guidance, with PhRMA calling it an “improvement” over the withdrawn guidance from 2017. Both groups say they support FDA’s move to combine its recommendations for comparative analytical assessment and quality considerations into a single guidance.

Both PhRMA and BIO also say they back FDA’s insistence that all biosimilar applications contain thorough chemistry, manufacturing and controls (CMC) information and support the agency’s approach to analytical testing described in the guidance.

The Association for Accessible Medicines (AAM) says it is “pleased that the draft guidance provides necessary clarity around the agency’s expectations and offers important flexibility for biosimilar developers.” AAM says it specifically appreciates that FDA removed a requirement for statistical equivalence testing and the general critical quality attribute (CQA) risk assessment concept proposed in the guidance.

However, AAM says it has some areas of concern within the guidance. First, AAM says that the guidance’s requirement for the biosimilar process “to be on the center of the reference product distribution” creates a stricter standard for biosimilars than for reference products.

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