Biotech Values

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In his concluding comments, Dr. Miletich urged the FDA to outline approval standards through a transparent and public process. "Not all classes of biological products have the same level of complexity or risk, thus class-specific approval standards must be developed," Dr. Miletich stated. "Case-by-case approaches generate uncertainty leading to delays and increased cost. Class-by-class standards are consistent with good review practices. A public process for approval standards creates confidence among patients and physicians."

Very good points here. Interested to hear MNTA CMO's key points.

EU antibody biosimilar standard comes out soon. MNTA might be able to get antibody biosimilar to EU first.