FDA Approves Humira Biosimilar That Won’t Be Available Until 2023

FDA Approved wording with man in suit giving thumbs up

The U.S. Food and Drug Administration (FDA) gave the green light to Hyrimoz, a biosimilar to AbbVie’s blockbuster drug Humira, five years ahead of the time it can be launched in U.S. markets. The biosimilar was developed by Sandoz, a subsidiary of Swiss pharma giant Novartis.

Hyrimoz (Adalimumab), is an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions-including rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis-causing inflammation. The FDA gave approval to Hyrimoz as a treatment for rheumatoid arthritis, juvenile idiopathic arthritis in patients four years of age and older, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

Regulatory approval in the U.S. was based on late-stage research that confirmed the pharmacokinetics, immunogenicity and safety of Hyrimoz. The study met the primary endpoint, demonstrating bioequivalence for all primary pharmacokinetic parameters, Novartis said in an announcement. A confirmatory efficacy and safety biosimilarity study demonstrated therapeutic equivalence in the sensitive indication of patients with moderate to severe chronic plaque-type psoriasis, with a similar safety and immunogenicity profile to the reference biologic, the company added.

Biosimilars, which are made inside a living cell, are always uniquely different in composition, which differentiates them from generic drugs, which are exact replicas of other drugs. They have been widely available in Europe since 2006, but the FDA only granted the right to review and approve them when Obamacare was passed in 2010.

Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said biosimilars are helpful options for patients suffering from chronic, debilitating conditions.

“With the FDA approval of Hyrimoz, Sandoz is one step closer to offering US patients with autoimmune diseases the same critical access already available in Europe,” Hendriks said in a statement.

Despite the Halloween regulatory approval, there was something of a trick rather than treat for patients looking forward to a Humira biosimilar. Hymiroz will not be available for sale in the United States until Sept. 30, 2023, under terms of intellectual property-related litigation with AbbVie.

AbbVie, the maker of Humira, has been highly protective of its product, which is the world’s best-selling drug. Last year, Humira generated more than $18 billion for the Illinois-based company and AbbVie has been fighting to preserve that revenue stream. AbbVie has created a thicket of patent protection in the United States that will prevent biosimilars being sold in the U.S. until 2023. It was only about two weeks ago that Humira began to face biosimilar competition in Europe per deals AbbVie struck to protect its cash-cow. In Europe, Humira is now being challenged by biosimilars developed by Amgen, Novartis, Samsung Bioepis and Mylan.

For Sandoz, Hyrimoz is the company's third approved biosimilar medicine in the U.S. Additional biosimilars for oncology and immunology indications are expected to launch globally across major regions by 2020, the company said.

When Hyrimoz is finally available in the U.S., it will be joined by two other Humira biosimilars, Amgen’s Amgevita and a biosimilar developed by Boehringer Ingelheim.

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