Biosimilar producer, Sandoz, has entered into a commercialization agreement for biosimilar, BAT1706, referencing Avastin (bevacizumab) with Bio-Thera Solutions for the treatment of multiple types of cancers.
PhRMA has called for the US FDA to ensure its capacity planning adjustment (CPA) methodology addresses the “unique needs” of the biosimilar review program.
WHO is recommending the use of interleukin-6 (IL)-6 receptor blockers in patients with severe and critical COVID-19, adding them to its list of treatments for the virus.
Bio-Thera Solutions recently initiated a Phase 3 trial of its proposed golimumab biosimilar BAT2506 in China and Eastern Europe, making it the first subcutaneous golimumab biosimilar to do so in multiple countries, according to a report from GlobalData.
Novartis subsidiary, Sandoz, says the US Supreme Court has denied its petition to review the Federal Circuit’s decision last summer in relation to Erelzi, its biosimilar of the Amgen reference medicine, Enbrel (etanercept), which is used to treat autoimmune...
The Medicines and Healthcare products Regulatory Agency (MHRA) has published final guidance on how the UK will license biosimilar products now it is outside of the European Union.
Roche witnessed a slight decrease in Q1 2021 pharmaceutical sales – a drop of 9% compared to the first three months of 2020 - as it faced continued biosimilars competition; the COVID-19 pandemic also played a role.
Efficiency in the biopharmaceutical space has never been more top-of-mind. The COVID-19 pandemic brought an unprecedented urgency to R&D and the key players delivered: Several groups produced a vaccine in record time. To maintain and improve on this...
A US court’s recent decision to find in favor of Sanofi and invalidate Amgen's broad antibody patent claims has biotech manufacturers concerned about how to preserve their IP.
Pfizer is selling a biologics manufacturing unit in the eastern city of Hangzhou to WuXi Biologics, despite the US pharma giant having ploughed US$350m into the site in 2016 to develop biosimilars.
