Legal Challenge To First Japan Rituxan Biosimilar Dismissed
First Japan legal ruling means biosimilar competition can continue to gnaw away at Rituxan, at least for now, as Chugai faces rising challenges to its mature oncology portfolio.
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The latest batch of product approvals in Japan positions Astellas’s roxadustat as the pioneer in the country’s potentially large HIF-PH inhibitor market in anemia, while Takeda and Meiji Seika see other important approvals and the first biosimilar teriparatide receives a nod.
First biosimilar version of Avastin approved in Japan, posing the first direct threat to Chugai's top product. But indications and timings mean the company expects limited impact this year.
Oncology again dominated new drug approvals in Japan last fiscal year, when expedited and special review pathways also played a major role in ensuring early access to new therapies.