Alvotech has revealed a US FDA goal date of 24 February 2024 for its refiled AVT02 proposed high-concentration interchangeable adalimumab biosimilar rival to Humira, as the firm provided further details of the resubmission – including an expected facility reinspection.

CEO of Enzene Biosciences weighs in on the impact of Medicare negotiations in the US on the biosimilars market even as a US filing is planned for a Prolia biosimilar. In the interview, he says Enzene “is not afraid or concerned” over ongoing litigation with Merck KGaA over an Erbitux biosimilar in India, adding that new modalities like ADCs are being “seriously” considered.

Alvotech has appointed a fresh chief operating officer as it continues to pursue a US approval for its adalimumab biosimilar. Meanwhile, Strides Pharma Science’s strategy head has left the company and Nick Haggar has joined Biocon’s board, while US association the AAM has also welcomed new staff.

With Alvotech once again asking the US FDA to approve its AVT02 high-concentration interchangeable adalimumab candidate after multiple knockbacks, the company says that the opportunity has not passed as the story of Humira biosimilars is “still being written.”