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US Biosimilar Outlook: Inspections, Interchangeability And Positioning For The Post-Humira Era

Executive Summary

Six of the 10 biosimilar candidates under FDA review are waiting on inspections delayed by COVID-19; in the meantime, sponsors jockey for position when Humira biosimilar launch windows open up next year.

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Coherus’ manufacturing scale for its Yusimry adalimumab biosimilar means it will “be able to drive the price down and to be able to provide supply guarantees,” management has insisted during a recent investor conference. “We think this will be very, very important.”

Alvotech Humira Settlement Sets Up Interchangeable Adalimumab Showdown

Alvotech and AbbVie have settled all of their legal disputes over Alvotech’s AVT02 biosimilar rival to Humira. With Alvotech seeking a coveted interchangeability designation for its higher-strength adalimumab, the firm’s US entry date provided by the settlement matches that of Boehringer Ingelheim’s interchangeable Cyltezo lower-strength adalimumab biosimilar.

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