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Responding to FDA’s draft guidance on immunogenicity assessment for therapeutic protein products, BIO says the agency should consider different principles when deciding procedures to detect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.
People have challenged patent listings more than 60 times in the past six years but it is up to new drug application holders to decide whether to revise or delist their submissions.