Amgen: Humira Interchangeability ‘A Nice To Have, Not A Need To Have’
‘Many’ Biosimilars Sponsors ‘Struggled’ With Key Issue Of Continuous Supply
Amgen management spoke at length about biosimilars during the company’s two-and-a-half-hour-long business review meeting, with the launch of its Amjevita (adalimumab-atto) biosimilar now less than a year away.
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180 Life Sciences has found that adalimumab can effectively treat nodule hardness and size in Dupuytren’s disease during a Phase IIb study. But, the company’s CEO Jim Woody tells Generics Bulletin, regulators in the UK and US have requested more information before they will press on with authorization.
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.
Amgen has reported positive preliminary results from a Phase III study for its ABP 654 proposed ustekinumab biosimilar rival to Stelara, for which the firm also intends to pursue an interchangeability designation.