First US Eliquis Generics Face Six-Year Wait
Mylan And Micro Labs Have Settled With BMS Over Apixaban
Mylan and Micro Labs have received the first FDA approvals for generic rivals to BMS’ Eliquis oral anticoagulant. However, as a result of the firms’ settlements with the originator, BMS does not expect the generics to hit the US market until 2026.
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ANDA filers that went to trial over Bristol Myers Squibb and Pfizer’s Eliquis blockbuster face a seven-year wait to launch their generic products after the US Court of Appeals for the Federal Circuit upheld a lower court decision.
Three ANDA sponsors – HEC’s Sunshine Lake, Sigmapharm and Unichem – for generic versions of Eliquis had elected to take their Hatch-Waxman case to trial but were soundly beaten by originator’s Bristol-Myers Squibb and Pfizer. A launch in 2031 could now be their best, and only, option.
Accord Healthcare is looking to breaking into the crowded market for biosimilar trastuzumab in the EU, after partner Henlius’ application was backed by the EMA’s CHMP. Meanwhile, a recommendation for a generic to the Eliquis anticoagulant was also forthcoming from the committee.