The US Food and Drug Administration has granted US market authorisation to Boehringer Ingelheim’s biosimilar anti-TNFa-antibody adalimumab.
Together with Amgen’s biosimilar version (Amjevita, adalimumab-atto) of Abbvie’s autoimmune blockbuster Humira, which received FDA approval last year, Boehringer Ingelheim (BI)’s Cyltezo (adalimumab-adbm) targets a market, in which Humira generated US$10.4bn (globally: 15.9bn) of revenues for last year. Earlier this month, Samsung Bioepis received EU market authorisation for its adalimuab biosimilar Imraldi (adalimumab). As Abbvie is in a patent battle with Boehringer Ingelheim and Amgen, it is still not clear when the biosimilars will be launched. While Abbvie claims that rival biosimilars to Humira couldn’t come to the US market before 2022, Amgen announced it will launch Amjevita, which received EU market authorisation in March, in 2017. BI expects the European Medicines Agency to provide an opinion on its pending MAA for its biosimilar adalimumab this year.
Though just clinically tested in rheumatoid arthritis, BI will be able to launch its version of the autoimmune drug in multiple chronic inflammatory indications including moderate to severe juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis and psoriasis. Under the strict US biosimilar regulations, the drug developer and CDMO has presented analytical, pharmacological, non-clinical and clinical data, which demonstrate that Cyltezo is biosimilar to Humira. While the FDA approval is for prefilled syringes, BI already presented study results at EULAR conference demonstrating pharmacokinetic comparability of an auto-injector of Cyltezo. The company said that it will also seek approval for this administration form.
Furthermore, Dr. Karsten Kissel, Head of Global Medical Affairs Biosimilars at BI, said in an interview that the company is going to conduct additional clinical studies with Cyltezo, i.e. in Morbus Crohn, in order to differentiate from competitors. According to Kissel, the adressable market for adalimumab biosimilars is large enough to make adalimumab biosimilars a business case for all companies that already have demonstrated comparability to Abbvie’s originator.
Besides established biosimilar makers such as BI, which has a 35-year track record in protein manufacturing due to its activities in drug development and as a CDMO, or Sandoz, Amgen, Pfizer and Samsung, expanding providers from the Eastern European Market are expected to increase competition in the biosimilar field. Most recently, Polish CDMO and biosimilar maker Polpharma Biologics made an €100m investment in an industrial scale production plant for biosimilar and biologics manufacture targetting the highly regulated US and EU markets.