Lack Of Interchangeability No Barrier For Amjevita, Says Amgen Executive
Company Expects Product To Receive Designation Some Time After January Launch
While Amgen’s Amjevita (adalimumab-atto) has yet to secure an interchangeability designation, company executives appear confident this will have little impact on their Humira biosimilar’s competitiveness overall.
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US FDA India country director Dr Sarah McMullen provides a fact check at a recent conclave to dispel the notion that interchangeable biosimilars are safer and more effective than other approved biosimilars.
Already approved in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland, and Canada, Alvotech’s AVT02 high-concentration biosimilar to Humira (adalimumab) will not be greenlit by the USFDA until the Icelandic firm resolved manufacturing deficiencies.
Two of Amgen’s flagship biosimilar products saw a notable drop in sales in Q1 in the face of increased competition, but impending launches are expected to put the unit back on track.