Bio-Thera’s Bevacizumab US Action Date Passes Without Approval
Chinese Developer And Partner Sandoz Remain Quiet On Fate Of Avastin Biosimilar
Bio-Thera Solutions had been hoping to become the first Chinese biosimilars developer to win an FDA approval, for its BAT1706 bevacizumab candidate. However, the announced FDA action date for the application has come and gone with no word from the company or regulator.
You may also be interested in...
While US biosimilar approvals have been somewhat thin on the ground in 2021 – with the pandemic driving inspection-related delays for multiple products – there were nevertheless several firsts this year, including the first two interchangeables and the first ophthalmic biosimilar.
While US biosimilar approvals have been somewhat thin on the ground in 2021 – with multiple products seeing action delayed due to the FDA’s inability to conduct certain facility inspections during the COVID-19 pandemic – the market has nevertheless seen several firsts this year, including two interchangeability designations and the first ophthalmic biosimilar approval.
Celltrion has indicated that it intends to leverage its ability to compete on cost to gain a foothold in the bevacizumab market, despite being a “latecomer” in the wake of firms that have previously launched and filed biosimilar rivals to Avastin.