Dive Brief:
- The Food and Drug Administration will decide whether to approve two biosimilar drugs this week: the agency will review Amgen's biosimilar (ABP-501) of AbbVie's Humira on Tuesday and Novartis' version (GP2015) of Amgen's Enbrel on Wednesday.
- In separate briefings over the past week, FDA staff concluded both biosimilars were "highly similar to" and without "clinically meaningful differences" from the original biologics, likely lining up a positive recommendation for the drugs.
- The proposed biosimilars are aimed at all uses of both Humira and Enbrel, threatening to heighten competition in a lucrative treatment area. Amgen is in an interesting spot, aiming to wrest market share from AbbVie's Humira, while simultaneously fighting to defend its own biologic Enbrel.
Dive Insight:
The potential approval of the two drugs may spell trouble for both AbbVie and Amgen.
Humira and Enbrel are the two respective companies' top-selling drug: Humira brought in $8.4 billion in U.S. revenue for AbbVie; and Enbrel netted $5.1 billion in U.S. sales for Amgen.
"Humira accounted for approximately 61 percent of AbbVie’s total net revenues in 2015. Any significant event that adversely affects Humira’s revenues could have a material adverse impact on AbbVie’s results of operations and cash flows," the company said in its 2015 annual report.
The adverse effects may appear less drastic for Amgen given its efforts to expand its portfolio, but Novartis' biosimilar pipeline could prove a real threat for the company. The company already competes with Amgen through its approved biosimilar of Neupogen, although that only threatens 5% of Amgen's total revenue.
But if Novartis' biosim is given a positive recommendation Wednesday, Novartis could compete with Amgen to steal sales of both Neupogen and Enbrel, which comprised over a quarter of Amgen's revenue last year.
The FDA is not required to follow the advice of its advisory panels, but usually does so.
In addition, Novartis has another biosimilar (of Amgen's Neulasta) pending FDA approval this year, which would open even more of Amgen's revenues to competition from Novartis.
Yet even if the drugs are approved by the FDA, AbbVie and Amgen still plan to defend their respective drugs' patents against Amgen and Novartis' Sandoz in court, as Bloomberg notes.
Meanwhile, consumer societies like the American College of Rheumatology (ACR) celebrate the opportunity for more competitive biologics markets. “The ACR welcomes the introduction of biosimilars to the U.S. healthcare system and is hopeful that the decrease in cost resulting from the availability of safe and effective biosimilars will help more patients to access and afford life-changing therapies," the college said in a statement.