Wednesday, September 7, 2022 Daily Archives

Iceland plant lands Alvotech’s Humira biosimilar CRL

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Alvotech’s Humira biosimilar has suffered a setback after the US FDA noted deficiencies relating to its Reykjavik, Iceland manufacturing facility in a complete response letter (CRL). Alvotech filed AVT02 – a version of AbbVie’s bestselling monoclonal antibody (mAb) Humira (adalimumab) – last year but this week announced the US Food and Drug Administration (FDA) has rejected the initial biosimilar Biologics License Application (BLA), due to issues at its manufacturing plant. After visiting the facility in Reykjavik, Iceland in March 2022,…

September 7, 2022

Biotimize looks to build first biological CDMO in Brazil

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Biotimize has opened a $30 million Series A funding round and says the investment will allow the firm to build the first biological CDMO in Brazil. Biotimize, a growth-stage biotechnology as a service (BaaS) firm, claims its fundraising round – if successful – will enable it to build the first biological contract development manufacturing organization (CDMO) facility in Brazil, which they claim will make it the first end-to-end biological CDMO in South America. The city of Piracicaba (about 100km northwest…

September 7, 2022