This morning, a divided Federal Circuit denied Amgen’s motion for a temporary injunction preventing Sandoz from marketing ZARXIO, its biosimilar version of Amgen’s NEUPOGEN filgrastim product. The appeals court, based in Washington, gave no reasons for rejecting Amgen’s bid.
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The investors are anxious about the potential for copycats to take business from original biotech drug brands.
Meanwhile, the USA biotech said it has submitted an application in Europe to market etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease on haemodialysis therapy.
Unlike generic drugs, which copy “classic” chemically-made drugs, biosimilars mimic biotechnology drugs made through more complex processes involving living cells.
The arrival of biosimilars threatens companies heavily reliant on biotech drugs, such as Amgen, AbbVie and Roche, and Citigroup analysts have predicted a transfer of at least US$110 billion of value from innovator companies to copycat producers in the next decade.
That represents a discount of 15 percent to Amgen’s list price and is the same price gap set when Zarxio was launched in Europe in 2009.
The drug industry and its lawyers are closely watching the Neupogen biosimilar case because the outcome could shape the path to market for a coming wave of biosimilar drugs that are expected to cost less than the original brands. The pricing is in line with the usual 15% to 30% discount on biosimilars in Europe, where they have been available for several years.
The drugs help the body create more white blood cells to fight off infections in cancer patients undergoing chemotherapy.
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The U.S. Food and Drug Administration approved Zarxio in March, but its introduction was delayed after Amgen sued.
