Amgen ($AMGN) has taken a big stride toward gaining regulatory approval for its biosimilar of Humira, AbbVie's ($ABBV) megablockbuster anti-inflammatory. The Big Biotech reports today that its knockoff of Humira--dubbed ABP 501--hit its marks on equivalency for efficacy and safety for treating plaque psoriasis.
Amgen didn't spell out the actual data, but it declared victory in the first of two planned Phase III studies comparing its follow-on drug with Humira (adalimumab), which made $10.7 billion last year for use against a range of diseases like psoriasis, rheumatoid arthritis, Crohn's disease, ulcerative colitis and more. Humira currently accounts for 60% of AbbVie's revenue and loses patent protection in the U.S. in 2016 and in Europe in 2018.
The primary endpoint of the Phase III was the Psoriasis Area and Severity Index, or PASI, percent improvement from baseline to week 16 of treatment.
Amgen was in the first wave of developers to stake out a plan to manufacture biosimilars, and Humira is a prime target in the field. Most analysts expect these biosimilars will carve 20% to 30% off the price of the branded biologic, a hefty discount but nothing close to the huge price cuts associated with traditional generics.
Amgen is also likely to face a host of newly approved biologics with a better efficacy and safety profile for psoriasis, including one of its own experimental therapies. Novartis ($NVS), Celgene ($CELG) and a partnership of AstraZeneca ($AZN) and Amgen for brodalumab have all been hard at work. And Amgen is not alone in developing biosimilars to Humira. Sandoz started its Phase III program for its knockoff at the end of last year. And Coherus, which is targeting niche markets, also has one in the pipeline.Sean Harper
"Results from Amgen's biosimilar Phase III plaque psoriasis study met the primary endpoint for efficacy and showed comparable safety and immunogenicity to adalimumab, which further demonstrates the company's commitment to provide patients with access to high-quality medicines," said Dr. Sean Harper, the head of R&D at Amgen. "We look forward to continuing to leverage our experience and expertise in biotechnology to bring biosimilars to patients."
- here's the release