Pfizer Will Not Launch EU Adalimumab
Despite Expected Imminent Approval For Amsparity Biosimilar To Humira
Pfizer has announced that it does not plan to market its Amsparity adalimumab biosimilar in Europe despite it having been endorsed by the EMA in December and being in line for an imminent approval from the European Commission.
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Mylan’s Hulio has become the sixth biosimilar version of Humira to be approved by the US FDA. However, all of these adalimumab biosimilars face a wait until 2023 before they can enter the market.
Japan has approved its first biosimilar rival to Humira. Mylan is set to market the Fujifilm Kyowa Kirin Biologics adalimumab biosimilar, having already launched the product as Hulio in Europe.
Samsung Bioepis has received a pan-European endorsement from the CHMP for its Aybintio bevacizumab biosimilar. The nod follows two previous European Avastin biosimilar approvals, with market formation believed to be imminent.