Amgen flexes biologics muscle as Humira biosim nails an equivalence test for RA
- In a phase 3 study, Amgen's biosimilar version of Humira (adalimumab), ABP 501, met its primary endpoint. It achieved a 20% improvement (ACR20) in symptoms in patients with rheumatoid arthritis (RA) at a statistically similar rate to AbbVie original biologic version of Humira.
- Last year, Humira generated roughly $12 billion in sales.
- Amgen has a distinct advantage in the biosimilar arena because of its 35 years of experience with biologics, including its success with Avastin, Neulasta, and Neupogen.
Earlier this year, Amgen expressed its intention to have up to five biosimilars on the market by 2019, including a biosimilar version of Humira. Amgen's biologics portfolio already generates roughly $8 billion in sales, and Amgen is determined to generate significant revenues from biosimilars as well.
A bit more about the phase 3 trial: The results were assessed at the 24-week mark and included the ACR20 for patients treated with ABP 501 instead of Humira. The response rare was 74.6% versus 72.4% respectively.
It should be noted that the results highlighted are only for RA, which is one of several indications for Humira. Other indications include moderate-to-severe plaque psoriasis, psoriatic arthritis and ankylosing spondylitis. There's a great deal of upside potential for Amgen—as well as the possibility of a drawn-out patent dispute with AbbVie. Regardless, the biosimilars industry is making real progress in the U.S., which bodes well for prices.