Long awaited FDA guidance on biosimilars is here. The FDA recently released three documents outlining their thoughts on biosimilars and the use of alternative drug delivery systems. Using alternative devices could potentially provide biosimilar developers an advantage over innovators by improving compliance. The FDA will reject any device that creates a ‘clinically meaningful difference’ between the safety, purity, and potency of a biosimilar and its reference. To read the full article, click here. To read the FDA guidance documents, click here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
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