Alvotech Receives Complete Response Letter on Second BLA for AVT02

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Alvotech Receives Complete Response Letter on Second BLA for AVT02


  • The US FDA granted a CRL for Alvotech’s second BLA of AVT02, a high-concentration biosimilar candidate for Humira. The agency rejected the drug’s BLA over deficiencies seen at one of the company’s manufacturing facilities in Reykjavik, Iceland & no other deficiencies was noted by the US FDA
  • The issues need to be resolved to facilitate the drug’s potential approval. The company plans to resubmit the BLA for AVT02 which will feature additional data supporting an interchangeability designation which would start another 6mos. review period
  • The company focuses to explore options aimed at raising capital, which incl. equity financing and the sale of convertible bonds or other forms of debt financing

Ref: Globenewswire | Image: Alvotech

Related News:- Teva's Partner Alvotech Receives Complete Response Letter on the BLA of AVT02 (biosimilar, adalimumab)


Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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