Pearce IP BioBlast: w/e 13 Mar 2020

Significant biosimilar activities this week include:

  • On 09 March 2020, the FDA and FTC held a public workshop to further their efforts in creating a better biosimilar landscape in the US. The Centre for Biosimilars reported that topics discussed at the conference included the damage caused by false and misleading statements and anti-competitive behaviour, and the regulatory impediments for launching biosimilars.
     

  • On 09 March 2020, the Korean Biomedical Review announced that Celltrion has submitted its application for CT-P17 (adalimumab) to the EMA. If approved, CT-P17 will be the first high-concentration adalimumab available.
     

  • On 09 March 2020, Henlius Biotech announced China's National Medical Administration had accepted its Investigational New Drug application for HLX14 (denosumab). HLX14 is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
     

  • On 09 March, the US Federal Court of Appeals for the Circuit Court affirmed the lower court's refusal to preliminary injunct Amgen for its sale of biosimilar trastuzumab. Trial is expected to begin on 20 April, 2020.
     

  • On 10 March 2020, Theradiag announced CE marking for its first four i-Tracker® test kits. The Infliximab, i-Tracker® Anti-Infliximab, i-Tracker® Adalimumab and i-Tracker® Anti-Adalimumab are designed to improve individual therapeutic drug monitoring and to allow clinicians to adjust treatment immediately. 
     

  • On 12 March 2020, Ankylosing Spondylitis News reported that Hisun Pharmaceuticals had completed Phase III trials of HS016 (adalimumab). Researchers concluded that HS016 was similar to adalimumab in terms efficacy and safety in the treatment of ankylosing spondylitis.
     

  • On 13 March 2020 J&J announced Dano® (ustekinumab) is now also indicated for the treatment of adults with moderate to severe Crohn's Disease. 

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November 9, 2020

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