China’s Bio-Thera is continuing its journey to bring biosimilars to patients across the globe, with its BAT1706 biosimilar bevacizumab candidate accepted for filing by the US Food and Drug Administration.
The US Food and Drug Administration has set a goal date under the Biosimilar User Fee Act of 27 November 2021 for Bio-Thera Solutions’ BAT1706 biosimilar bevacizumab candidate, having accepted for filing the Chinese firm’s biologics license application referencing Roche’s Avastin oncology blockbuster.
Bio-Thera is seeking approval for its biosimilar from the FDA for all US-licensed Avastin indications, including metastatic colorectal cancer and non-squamous non-small cell lung cancer
Eight more ANDA filers remain in play challenging patents shielding Esperion’s Nexletol (bempedoic acid) after Micro Labs deal out litigation via a settlement agreement.
Teva underlined that it was “very pleased with this franchise we’re building and what we’ll bring to the care of patients with schizophrenia,” as it looks ahead to filing its olanzapine new drug application in the second half of 2025.
Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.
