Dive Brief:
- 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.
Dive Insight:
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.