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Pfizer’s FDA-Approved Adalimumab Faces Four-Year Wait

Abrilada May Launch From Late 2023 Under A Settlement With AbbVie

Executive Summary

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.

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Alvotech has announced the filing of its AVT02 higher-strength adalimumab version of Humira 100mg/ml with both the FDA and the EMA, as well as disclosing expected decision dates. Teva will market the biosimilar in the US and Stada in Europe.

AAM Sees ‘Red Flag’ In IQVIA Biosimilars Report

While the latest IQVIA data points to accelerated uptake of US biosimilars over the next five years, with associated increases in spending and savings, local off-patent industry association the AAM says the report raises a “red flag” over long-term market sustainability.

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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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