Criticism Of FDA's Limited Proof-Of-Principle Ignores The Full Breadth Of Biosimilar CQA Understanding

Critics say adalimumab and trastuzumab, two of the most well-characterized antibodies on the market and each with their several approved biosimilars, provide a limited basis for proof of principle. During Bioprocess Online Live: Process Control's Increasing Role In Biosimilar Approval, panelists agreed that the full body of evidence includes approved biosimilars with diverse mechanisms of action and complex glycostructures.

"The same standards and thinking apply to all molecules," said Cecilia Michel, managing director and head of research and development strategy at Alvotech. "Even if the same extensive case study hasn't been performed on these other approved biosimilars, the sponsors, as well as the FDA and other regulatory agencies across the world, they've all scrutinized this data and decided that this is sufficient data to reach approval and obviously compare and contrast the analytical comparability package and the PK data and the CES study."