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The US Food and Drug Administration (FDA) has responded completely to Alvotech’s Biologics Licence Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira (adalimumab), according to a press release from the international biotech company Alvotech. The FDA’s reinspection of…
Amgen (NASDAQ:AMGN) today announced AMJEVITA™ (adalimumab-atto), a biosimilar to Humira®* (adalimumab), is now available in the United States. AMJEVITA was the first biosimilar to Humira approved by the U.S. Food and Drug Administration (FDA), in 2016.(1,2)“With today’s announcement, AMJEVITA is…
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