Adalimumab biosimilar recommend for FDA approval

An FDA advisory panel voted unanimously in favor of Amgen’s cheaper version of adalimumab, saying it is similar in safety and efficacy to AbbVie’s Humira

ABP 501 was studied in rheumatoid arthritis and plaque psoriasis, but the panel concluded that the data could be extrapolated to other conditions for which adalimumab is approved, including adult Crohn's disease and ulcerative colitis, and should be approved for those conditions as well.

Amgen did not apply for last week’s newly approved indications for Humira, including non-infectious uveitis, due to existing regulatory exclusivity.

However, even with FDA approval, it could take several years before Amgen’s copy reaches the market. AbbVie has repeatedly told its investors that it has patents in place to protect Humira in the United States until at least 2022. The world’s best-selling medicine last year accounted for 60% of AbbVie’s total revenue, and generated more than $8 billion in U.S. sales.

Ironically, a separate FDA panel this week voted to approve of Novartis’ biosimilar of Amgen’s arthritis drug etanercept (Enbrel). Like adalimumab, etanercept works by blocking tumor necrosis factor (TNF), which plays a wide role in inflammatory conditions. Novartis, through its generics division Sandoz, tested the drug GP2015 in patients with plaque psoriasis and found that it had a similar efficacy and safety profile as etanercept.

Amgen has filed suit against Sandoz, claiming the company is "piggybacking on the fruits" of their research efforts. Additionally, Sandoz is also developing its own adalimumab biosimilar which is expected to arrive sometime over the next 4 years.