- Amgen on Friday gained approval from the U.S. Food and Drug Administration for Amjevita, the first biosimilar of AbbVie's blockbuster anti-inflammatory drug Humira (adalimumab).
- Amjevita was approved for seven of Humira's indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, chronic plaque psoriasis, adult Crohn's disease and ulcerative colitis.
- Amjevita is the fourth biosimilar approved by the FDA, and Amgen's first. "The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions," said Janet Woodcock, director of the Center for Drug Evaluation and Research, in a statement.
Amgen was once king of biologics, but has given up ground as other companies began developing the large molecule drugs as well. Amjevita is the first of the company's biosimilar products approved — the California-based biotech has a number of other biosimilars in its pipeline, including copies of Roche's cancer drugs Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxin (rituximab), as well as J&J's Remicade (infliximab) and Eli Lilly's Erbitux (cetuximab).
The approval of Amjevita was based on two Phase 3 studies in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis. The studies showed clinical equivalence, as well as comparable safety.
Amjevita is currently undergoing review in Europe by the European Medicines Agency under an application that was submitted in December 2015.
AbbVie's tumor necrosis factor (TNF) blocker is one of many such drugs on the market. Originally approved in 2002, Humira is currently approved for rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, chronic plaque psoriasis, adult and pediatric Crohn's disease, ulcerative colitis, uveitis and hidradenitis suppurativa. The drug brought in about $14 billion in worldwide sales in 2015, making up about 60% of AbbVie's total revenues.
Yet, it will likely be some time before the biosimilar version actually becomes available to patients. AbbVie is currently duking it out with Amgen in court, accusing the big biotech of infringing on 10 of Humira's patents.
AbbVie has said previously it believes it can hold off the generic version of its best-selling drug until 2022. But Amgen isn't the only one trying. Merck & Co., along with partner Samsung Bioepis, and Shire (in conjunction with Momenta Pharmaceuticals) are also developing their own biosimilar versions of the blockbuster drug.
Amgen, while it has lined up a number of biosimilar candidates for approval in the U.S., is also playing defense in the race to develop biosimilar copies of top-tier biologics. The company has sought to stave off Novartis' efforts to steal some of its market share, although the Swiss pharma has already won approval for a biosimilar copy of Amgen's Neupogen and Enbrel.
Other brand-name pharma companies have also been active in developing copycat biologic drugs. Pfizer, Merck and Biogen have partnered with biosimilar drugmakers, for instance.