Alvotech (Buy, TP: USD13.00) - Another CRL for AVT02 in the US
Alvotech reported late last week that it has received another CRL for the second BLA regarding AVT02 (Humira high-concentration biosimilar with interchangeability). In our view, this is bad news, as a re-inspection of the Reykjavik facility seems necessary and a re-filing of the BLA (triggering a 6-month review period) should lead to an approval in early 2024 (the original plan was to launch in early July this year). The delayed launch will trigger a need for additional cash, and the company highlighted that it is exploring financing alternatives.
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