Significant biosimilar activities this week include
09 Mar 20 | 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.
09 Mar 20 | 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.
09 Mar 20 | 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.
09 Mar 20 | 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.
10 Mar 20 | 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.
12 Mar 20 | 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.
13 Mar 20 | J&J announced Dano® (ustekinumab) is now also indicated for the treatment of adults with moderate to severe Crohn’s Disease.