AbbVie’s Humira (adalimumab) looks set to be on the defensive in Europe as well as the US this year, after the CHMP backed two biosimilar versions of the world’s best-selling drug.
Amgen’s biosimilars – Amgevita (ABP 501) and Solymbic – were recommended for approval by the EMA’s scientific advisory panel in rheumatoid arthritis (RA), to treat moderate to severe RA in adults where methotrexate is inadequate and adults with severe RA who have had no prior methotrexate therapy.
Both are intended for a wide range of Humira’s currently approved indications, including juvenile idiopathic arthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease and ulcerative colitis.
The two TNF inhibitors are not only the first biosimilars to receive a positive opinion this year, but the first versions of Humira to be backed by the CHMP.
Amgen’s executive vice president of R&D Sean Harper said: “This represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases.”
However, Humira still has patent protection in the EU until April 2018 and so Amgen looks set to face an uphill struggle to launch the biosimilars in European markets.
The company is already engaged in a dispute over Amgevita in the US where it has recently been licensed, with AbbVie filing an infringement lawsuit against Amgen.
AbbVie has also sought an injunction to prevent its launch even after FDA approval.
The $13bn-a-year global brand, which currently accounts for 60% of AbbVie’s revenues, reached its US patent deadline at the end of 2016 but the firm is looking to extend its protection until 2022.