Pearce IP BioBlast: w/e 06 Mar 2020
Significant biosimilar activities this week include:
On 02 March 2020, Celltrion launched Remsima SC, its subcutaneous infliximab product, in the UK. To support the launch, Celltrion held a symposium at which it showcased the product and supporting data. Celltrion has signed a framework agreement with the NHS to supply the product.
On 03 March 2020, China's National Health Commission released new treatment guidelines for SARS-CoV-2 which included the use of Roche's Actemra (tocilizumab) to treat patients with serious lung damage and high IL-6 levels. At this stage, there is no clinical trial evidence that shows the drug will be effective on coronavirus, however clinical trials are ongoing, with trials expected to end on May 10. The product is yet to be approved for use in treating patients with SARS-CoV-2.
On 05 March 2020, the Federal Circuit Court affirmed the District Court's judgement of non-infringement in the Celltrion v Janssen (infliximab) matter.
On 06 March 2020, in its 2019 Q4 earnings call, Mylan announced the FDA has accepted its aBLA for a proposed bevacizumab biosimilar. The FDA's decision is expected on or before December 27, 2020.