Boehringer Ingelheim has released positive phase III data for Cyltezo (adalimumab-adbm), its biosimilar version of AbbVie’s blockbuster arthritis treatment Humira.
The one-year VOLTAIRE-RA study of 645 adults with moderately-to-severely active rheumatoid arthritis, showed Cyltezo is equivalent, with no clinically meaningful difference in efficacy, safety and immunogenicity, to Humira.
Karsten Kissel, head of global medical affairs biosimilars, Boehringer Ingelheim, said: “These data are an important addition to the robust body of evidence demonstrating Cyltezo is biosimilar to Humira.
“Biosimilars have potential cost benefits to the healthcare system and support affordable access to important biologic medicines for patients living with inflammatory disease like RA.”
Though not on the European market just yet, Cyltezo is set to gain a licence within the coming months after receiving a position opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). That recommendation covered its use to treat adults with multiple chronic inflammatory diseases, including moderate to severe active rheumatoid arthritis, psoriatic arthritis and moderate to severely active Crohn’s disease.
The CHMP also recommended Cyltezo for paediatric patients, in indications such as moderate to severe Crohn’s disease, severe chronic plaque psoriasis, enthesitis-releated arthritis, and polyarticular juvenile idiopathic arthritis.
Usually, a CHMP opinion would be a big confidence boost to a pharma firm looking to market its product in the EU, however Boehringer and AbbVie are currently locked in US patent litigation trial in the US, ensuring Boehringer treads carefully in Europe.
Consequently, Boehringer has said that it “does not intend to launch Cyltezo in the EU before expiration of the respective SPC for adalimumab in October 2018”.
In the US AbbVie wants to keep Cyltezo off the market, claiming it will infringe 74 of its patents. However, Boehringer will still push on with presenting its new data at the forthcoming Association of Rheumatology Health Professionals annual meeting in California, US.
Meanwhile, in a similar suit, AbbVie has successfully blocked US marketing of Amgen’s biosimilar version of Humira up until 2023, although in this case AbbVie only claimed Amgen was infringing on ten of its patent rights.