Boehringer Ingelheim receives approval for its biosimilar of Humira.

For the second time, the FDA has approved a biosimilar of AbbVie’s anti-inflammatory drug Humira. Amgen received approval for its biosimilar Amjevita (adalimumab-atto) across all eligible indications of the reference product in September 2016. Now Boehringer Ingelheim (BI) has received FDA approval for Cyltezo (adalimumab-adbm).

BI received approval to manufacture Cyltezo at its facility in Fremont, California. The company is upgrading and expanding capacity at the plant at a cost of $217 million. It is the first biosimilar from BI to receive FDA approval. The approval was based on “a comprehensive data package comprised of analytical, pharmacological, non-clinical and clinical development studies demonstrating that CyltezoTM is biosimilar to Humira®.” BI expects to receive an opinion of the marketing authorization application for this biosimilar candidate from the European Medicines Agency later in 2017.

The drug will be offered in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, plaque psoriasis. BI also plans to seek approval for an auto-injector of CyltezoTM as another delivery option for patients. CyltezoTM is not yet commercially available, however, due to the fact that BI is currently engaged in patent litigation with AbbVie.

In addition to CyltezoTM, Boehringer Ingelheim currently has BI 695502, a bevacizumab biosimilar candidate to Avastin® in late stage development. The company is also pursuing an interchangeability study with CyltezoTM and the US-marketed formulation of Humira®, 40mg/0.8mL (study name VOLTAIRE-X). 

“CyltezoTM is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and CyltezoTM has the potential to deliver significant benefits to many of these individuals.”