Amgen Optimistic Over Inflammation Biosimilars Ahead Of Ustekinumab
Patient Enrollment Complete For Phase III Stelara Biosimilar Study
Amgen has once again touched on its impending expansion into US inflammation/immunology biosimilars, with launches for adalimumab and ustekinumab scheduled for the coming years.
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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.
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.
Bio-Thera Solutions had been hoping to become the first Chinese biosimilars developer to win an FDA approval, for its BAT1706 bevacizumab candidate. However, the announced FDA action date for the application has come and gone with no word from the company or regulator.