Accord Healthcare has announced the launch of a Herceptin biosimilar in the UK. Zercepac is the first monoclonal antibody (mAb) and fourth biosimilar launched by the company in Europe.
Janssen aims to expand the label of delivery in the US and EU for its product, Darzalex, to include subcutaneous delivery through the use of Halozyme’s technology.
Mundipharma partners with Prestige to commercialize and supply a biosimilar to Roche’s Herceptin, for patients with breast, gastric and gastroesophageal cancer.
Amgen’s biosimilars portfolio reaches a milestone after its Herceptin biosimilar, Kanjinti, developed in collaboration with Allergan, was approved by the US FDA.
Genentech receives US FDA approval on Herceptin Hylecta, a subcutaneous co-formulation using Halozyme’s recombinant Enhanze technology, for the treatment of HER2-positive metastatic breast cancer.
The US regulator has validated Celltrion and Teva’s biosimilar version of Roche’s Herceptin, marking the partnership’s second approval in as many months.
The first MabThera biosimilar is expected to enter the US market in the first half of 2019, followed by Herceptin and Avastin versions in the second half of the year, says CEO.
