Boehringer Ingelheim has won its first biosimilar approval in Europe with authorisation of Cyltezo for a range of chronic inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
Cyltezo (adalimumab) is a biosimilar of AbbVie’s Humira, an anti-TNF monoclonal antibody that pulls in annual sales of nearly $15 billion across its range of indications for inflammatory diseases. Biosimilar versions are expected to be significantly cheaper, and thus have the potential to generate substantial savings for healthcare providers.
“Cyltezo is the first biosimilar from Boehringer Ingelheim approved in Europe, and marks a significant step forward for us in offering effective, and more affordable treatment options for patients with chronic inflammatory diseases,” said Ivan Blanarik, senior vice president and head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “We believe biosimilars will be a key contributor to the future sustainability of healthcare systems around the world.
The drug’s approval, which also covers various paediatric inflammatory diseases, rides on the back of a “comprehensive data package supporting the biosimilarity of Cyltezo to Humira comprising analytical, pharmacological, non-clinical and clinical data,” according to the firm.
However, BI said it does not intend to make the drug commercially available in Europe until the respective SPC (supplementary protection certificate) for adalimumab, which extends the duration of certain rights associated with a patent, expires in October 2018.
Cyltezo is also not yet available in the US despite its approval there in August, because of ongoing patent litigation with AbbVie. AbbVie reportedly holds more than 100 patents on Humira, and believes that Boehringer could infringe 74 of these with the launch of its biosimilar. Similarly, the firm has also taken Amgen to court to block the launch of its proposed Humira biosimilar.