US FDA approves Novartis’s biosimilar copy of Amgen’s Enbrel
01 Sep 2016
Novartis has won US approval for a copy of Amgen's blockbuster arthritis drug Enbrel, but there are court battles that the Swiss drug maker would need to fight before the medication with $4.7 billion in annual US revenue can be sold in the market.
Novartis's Sandoz unit said on Tuesday that Erelzi, its biosimilar copy of Enbrel, had been approved by the US Food and Drug Administration (FDA) approved for rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and other diseases.
However, Erelzi remained stuck as US courts had ruled that makers of biosimilars would need to wait 180 days after winning FDA approval before beginning sales of the near-copies.
According to commentators, this could block Erelzi's sales launch until March 2017.
Amgen is also locked in a patent war, as it looks to keep Novartis off Enbrel's turf by arguing in US federal court its drug had patent protection until 2029.
"We are fully committed to bringing Erelzi to US patients and payers as soon as possible," Novartis said in a statement.
The statement added, "However, we cannot speculate on product commercial availability."
Biosmiliars aimed to copy biologic products made by living cells.
Meanwhile the FDA said is a presse release Erelzi is administered by injection for the treatment of:
- Moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
- Moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
- Active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
- Active ankylosing spondylitis (an arthritis that affects the spine); and
- Chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.
Healthcare professionals should review the prescribing information in the labeling for detailed information about the approved uses.
''The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases,'' said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research.
''We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product.''
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