Biosimilar Vs. Therapeutic Protein Immunogenicity: Industry Makes Distinction
Responding to FDA’s draft guidance on immunogenicity assessment for therapeutic protein products, BIO says the agency should consider different principles when deciding procedures to detect immune response to biosimilars; Momenta wants the agency to draw a distinction between immunogenicity and safety testing.
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In comments on FDA’s three biosimilar draft guidances, PhRMA and BIO seek a more limited role in biosimilar approval decisions for clinical data involving foreign reference products than does GPhA, but all the trade associations believe that the foreign product needs to be made by the same company in the same facility as the U.S.-licensed reference product.
The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.
Delaware district judge rules against AstraZeneca’s claim the IRA violates its due process rights, echoing findings made by Ohio district judge in Chamber of Commerce’s suit. Only other IRA ruling to date dismissed PhRMA’s complaint on procedural grounds without addressing the merits.