Japan Approves First Humira Biosimilar
Mylan Will Market Fujifilm Kyowa Kirin’s Adalimumab Rival In Japan
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.
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Settlement agreements reached by Humira biosimilar chasers Amgen, Samsung Bioepis and Sandoz in 2017 and 2018 were challenged in court by adalimumab purchasers, which alleged they formed were a part of a broader scheme to hold up competition to the multi-billion-dollar blockbuster brand in the US. But the biosimilar firms and AbbVie will not have to face the antitrust claims.
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.
Pfizer has secured FDA approval for its adalimumab biosimilar under the name Abrilada, representing the agency’s 25th biosimilar approval overall. However, patent settlements around the Humira brand mean that Pfizer is not due to enter the market for four years.