Drugs

General, Specific Comments on Analytical Similarity Guidance

The Biosimilars Forum is calling on FDA to build appropriate flexibility into a final guidance on statistical approaches to evaluate analytical similarity, taking into account the complexity of the subject matter and its applicability to diverse biosimilar development programs. In its comments on a draft guidance, the group says that the approaches outlined in the draft are complex and warrant product-specific discussion with the agency very early in development. It says the draft guidance should encourage sponsors to contact FDA early in the product development process to discuss lot selection and risk ranking of attributes and initiate discussions regarding the analytical similarity plan and statistical analysis plan. “Due to the stepwise process of biosimilar development,” the letter says, “FDA should be prepared to facilitate discussion very early in development discussions in order to ensure there is no misinterpretation of expectations from the outset, and continue with follow up discussions as needed through development as more information is gained.”

Sandoz offers general comments on limitations on statistical approaches for biosimilarity assessment, source of reference product material, and possible justification to claim high similarity in the context of a failed equivalence test, as well as line-by-line specific comments.

Shire’s letter says it supports FDA’s overall efforts in further elaborating on implementation of the Biologics Price Competition and Innovation Act by developing and issuing guidance documents. It also gives comments on specific items in the text.

Amgen gives general comments on consultation between the agency and sponsors, quality attributes, challenges and limitations to applying statistical analyses in the evaluation of analytical similarity data, and tiering.

Finally, Sanofi’s letter provides specific line-by-line comments and recommendations.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome