Court ruling paves the way for launch of Sandoz’s Zarxio as first US biosimilar
Jul 22, 2015
Holzkirchen, Germany, July 22, 2015 - The US Court of Appeals for the Federal Circuit issued a ruling on July 21 that paves the way for Sandoz to launch Zarxio (filgrastim) after September 2, as the first US biosimilar.
The court, which ruled following an appeal hearing on June 3, found that provision of the biosimilar application to the originator company within 20 days of filing – the so-called “patent dance” component of the US biosimilar approval pathway, or BPCIA -- is optional.
However, it also ruled that the required notice of commercial marketing can only be provided to the brand company following FDA product approval, but must be at least 180 days before commercial marketing. Sandoz gave a further notice of commercial marketing when it received FDA approval of Zarxio on March 6, so it can launch 180 days from then, i.e. after September 2.
Carol Lynch, Global Head of Sandoz Biopharmaceuticals & Oncology Injectables, said: “We welcome the Federal Circuit’s finding that the BPCIA's patent dance is optional.
“As we have argued all along, the decision of a biosimilar applicant not to provide its dossier as one step in the patent dance entitles the brand under the BPCIA to commence patent infringement proceedings, which Amgen has done here.
“We look forward to launching Zarxio after September 2 as the first US biosimilar.”
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About Sandoz Sandoz, a division of Novartis, is a global leader in generic pharmaceuticals, driving sustainable access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and supplies a broad range of affordable products to patients and customers around the globe.
The Sandoz global portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1 position in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines. Sandoz also holds leading global positions in key therapeutic areas ranging from generic injectables, dermatology and respiratory to cardiovascular, metabolism, central nervous system, pain and gastrointestinal.
Sandoz develops, produces and markets finished dosage form (FDF) medicines as well as intermediary products including active pharmaceutical ingredients (APIs) and biotechnological substances. Nearly half of the Sandoz portfolio is in differentiated products – medicines that are scientifically more difficult to develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has consistently driven growth in selected geographies and differentiated product areas through a series of targeted acquisitions, including Hexal (Germany), EBEWE Pharma (Austria), and Fougera Pharmaceuticals (US).