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Responding to FDA’s draft guidance on immunogenicity assessment for therapeutic protein products, BIO says the agency should consider different principles when deciding procedures to detect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.
You may also be interested in...
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.
Agencies seek public comment on how they can modernize merger guidelines to enforce antitrust laws. List of questions, including what types of evidence show that a merger could reduce competition, indicate pharma and other mergers will face greater scrutiny.