China’s Bio-Thera Solutions has ventured outside of its domestic market for the first time by filing an application for a biosimilar version of Avastin with the European Medicines Agency. The company has also revealed its timeline for a submission to the FDA.
Bio-Thera Solutions has taken a first step outside of its home market of China by filing an application for a biosimilar version of Avastin (bevacizumab) with the European Medicines Agency.
“The submission of the marketing authorization application for BAT1706 marks a milestone for Bio-Thera as the first ex-China MAA or biologics license application submission,” the firm’s founder and CEO Shengfeng Li remarked, with the company confirming that it was seeking authorization “for
The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.
Thanks to its efficient development pipeline, sales of Amgen’s biosimilars neared $750m for the first three months of the year, offering some comfort as the firm gears up for the loss of exclusivity for its denosumab franchise.
During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.
As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.
