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Court ruling paves the way for launch of Sandoz’s Zarxio as first US biosimilar

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.”

The foregoing release contains forward-looking statements that can be identified by words such as “launches,” “introduction,” “will,” or similar terms, or by express or implied discussions regarding potential revenues from guanfacine extended release tablets. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that guanfacine extended release tabletswill be commercially successful in the future. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general, including potential approval of additional versions of guanfacine extended release tablets; national trends toward health care cost containment, including ongoing pricing pressures; unexpected patent litigation outcomes; unexpected manufacturing issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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).

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For further information:

Sreejit Mohan
Sandoz Global Communications
+49 (0) 162 429 7971 

Chris Lewis
Sandoz Global Communications 
+49 8024 476 1906