STAT February 13, 2020
The Nobel Prize in Medicine will never be awarded for excellence in the formulation and manufacture of biologic medicines. That’s understandable.
Yet making effective and safe biologic products, including biosimilars, is incredibly important for patients and valuable for our health care system. Quality manufacturing is essential to our ability to provide consistent products for patients, and to provide them in a way that is scalable for the thousands — sometimes millions — of doses that will be needed.
Patients who need these medicines deserve the product the Food and Drug Administration approved, whether that’s the reference biologic or a biosimilar, not an adulterated or inadequate version of it. FDA regulations and guidance along with regulatory pathways are designed to assure...
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