The FDA has started its review of a biosimilar of AbbVie’s blockbuster Humira developed by Novartis’ generics unit Sandoz, setting up a possible approval later this year.
The biosimilar is vying to be the third copycat version of AbbVie’s Humira (adalimumab) in the big US market after Amgen’s Amjevita and Boehringer Ingelheim’s Cyltezo. Biosimilars are hoping to capture a share of the massive market for Humira – which is currently the top-selling drug in the world, heading for $16bn in sales this year, and according to AbbVie could hit $21bn in 2020.
Assuming approval is forthcoming from the regulator, the timing of a launch is up in the air. Amgen recently agreed a non-exclusive licensing deal with AbbVie as part of a patent-infringement dispute that will delay the launch of its biosimilar in the US until 2023, although it will be able to launch in Europe this year.
The drug still accounts for two-thirds of AbbVie’s revenues although it has made strenuous efforts to diversify into areas such as cancer and hepatitis C, and has high hopes for new launches such as blood cancer therapies Imbruvica (ibrutinib) and Venclexta (venetoclax).
In a trial reported last September Sandoz’ biosimilar matched the safety and efficacy of Humira in patients with plaque psoriasis, with almost 80% of patients experiencing a 75% improvement in symptoms by the end of the study.
Sandoz has already filed its Humira biosimilar in the EU, seeking approval as a cheaper alternative to AbbVie’s drug in several immunological diseases, including psoriasis, rheumatoid arthritis and inflammatory bowel disease.
“When patients are dealing with a chronic disease, it is imperative they have access to important medication that will help best manage their health.” said Mark Levick, Sandoz’ global head of biopharmaceuticals development.
“The FDA’s acceptance of the regulatory submission for our biosimilar adalimumab brings us one step closer to offering a portfolio of options to the millions of patients in the US who suffer from an inflammatory disease.”