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Alvotech Reaches PCD in its Switching Study for AVT02 (Proposed Biosimilar to Humira)

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Alvotech Reaches PCD in its Switching Study for AVT02 (Proposed Biosimilar to Humira)

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  • The purpose of the switching study (AVT02-GL-302) is to support the approval of AVT02 in the US as an interchangeable biosimilar product with the high concentration (100mg/mL) dosage forms of Humira. The results of the study are expected in late 2021
  • In May’21- Alvotech sued to end AbbVie’s wrongful monopoly on Humira and bring an affordable arthritis treatment to the US
  • In Nov’20- the US FDA and EMA has accepted Alvotech’s regulatory submissions for AVT02. The company expects FDA’s decision in Sept’2021 and EMA’s decision in Q4’21

  | Ref: BUSINESS WIRE | Image: BUSINESS WIRE

Click here to­ read the full press release 

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