Pearce IP BioBlast: f/e 28 Feb 2020
Significant biosimilar activities this fortnight include:
On 24 Feb 2020, the FDA launched a searchable version of the 'Purple Book', containing information about FDA licensed biological products.
On 24 Feb 2020, Canadian News Agency Folio drew attention to a study released by the University of Alberta revealing doctors may face legal and ethical challenges when switching patients to biosimilars. The study suggests that despite a body of evidence supporting the safety of biosimilar products, doctors may be conflicted by their duty to act in the best interests of their patients. As a result, doctors may be required to disclose the safety, controversies and perspectives of those who oppose switches and the patient's ability to access unfunded biologics. This comes as the Alberta Government plans to defund biologics on government-sponsored plans by July 1.
On 26 February 2020, Sandoz's US President announced a focus on biosimilars and complex generics as it re-prioritises its US portfolio. As part of the re-prioritisation, Sandoz will sell much of its small molecule generics portfolio to Aurobindo Pharma.
On 28 February 2020, Harbour BioMed announced FDA approval of its Investigational New Drug application for HBM4003, an anti-CTLA-4 antibody and candidate for the treatment of advanced solid tumours.
Despite receiving CHMP approval earlier this month, Pfizer has announced it does not currently plan to launch Amsparity (adalimumab) in the EU, citing unfavourable market conditions.