Industry Groups Support FDA’s Latest Biosimilar Analytic Assessment Guidance
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pharmaceutical, biologic and biosimilar manufacturers say they support the US Food and Drug Administration’s (FDA) draft guidance on comparative analytical assessment and other quality-related considerations for developing biosimilars, though some sticking points remain.The 28-page draft guidance revises the agency’s 2015 guidance on quality consideration for demonstrating biosimilarity and replaces a 2017 draft guidance on statistical approaches to evaluating biosimilarity that was withdrawn last year.
PhRMA and the Biotechnology Innovation Organization (BIO) say they support the draft guidance, with PhRMA calling it an “improvement” over the withdrawn guidance from 2017.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The Association for Accessible Medicines (AAM) says it is “pleased that the draft guidance provides necessary clarity around the agency’s expectations and offers important flexibility for biosimilar developers.”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.
Both PhRMA and AAM also ask that FDA revise the wording used in the section on reference standards, which as written recommends “for all methods where the result is reported relative to the reference standards, the assignment of a potency of 100% should include a narrow acceptable potency range and ensure control over product drift.”
PhRMA argues that the “potency of subsequent reference standards in a product lifecycle may change” and asks that FDA acknowledge in the final guidance that in some situations a correction factor or “the assignment of a stated potency which can deviate from 100%.”
AAM also requests that FDA allow biosimilar sponsors to pool non-US licensed comparators and US reference product lot data “once the scientific bridge between a US and non-US product has been established.”
While AAM says it welcomes the flexibility shown in the guidance with regards to the number of lots of reference product (at least 10) and the biosimilar candidate (at least 6-10), PhRMA argues that “the usage of too few lots of reference product might make it challenging to determine whether the proposed biosimilar product in fact meets the standard for biosimilarity.” PhRMA also refers to a passage from FDA’s 2015 guidance on Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, which states that “FDA anticipates that more data and information will be needed to establish biosimilarity than would be needed to establish that a manufacturer’s post-manufacturing change product is comparable to the pre-manufacturing change product.”
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