FDA approves first biosimilar (filgrastim-sndz) from Sandoz

  • Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under BPCIA
  • Sandoz biosimilar filgrastim is approved for all indications included in the reference product’s label
  • Approval paves way for greater access to high-quality biologics in the US and underscores Sandoz global leadership in biosimilars
6. 3. 2015

Sandoz, a Novartis company, announced today that the US Food and Drug Administration (FDA) approved Sandoz biosimilar filgrastim (filgrastim-sndz) for all indications included in the reference product’s label. Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. The approval was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Sandoz biosimilar filgrastim is highly similar to the US-licensed reference product. The approval of Sandoz biosimilar filgrastim follows the unanimous positive vote in January by the Oncologic Drugs Advisory Committee (ODAC).

“The FDA approval of Sandoz biosimilar filgrastim marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia,” said Carol Lynch, Global Head of Biopharmaceuticals & Oncology Injectables at Sandoz. “As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US.”

“Filgrastim has proven clinical value in treating patients at increased risk of neutropenia, but it is underused in the US for a variety of reasons, including price” said Dr. Louis Weiner, chairman of the department of oncology and director of the Lombardi Comprehensive Cancer Center at Georgetown University. “Biosimilars have the potential to increase access and the approval of Sandoz biosimilar filgrastim may reduce costs to the healthcare system. The comprehensive data set supports its use in clinical practice.”

The successful Sandoz pivotal head-to-head PIONEER study was the final piece of data contributing to the totality of evidence used by FDA to approve Sandoz biosimilar filgrastim as biosimilar to the reference product. Importantly, the data demonstrating high similarity was sufficient to allow extrapolation of use of Sandoz biosimilar filgrastim to all indications of the reference product. In the PIONEER study, Sandoz biosimilar filgrastim and the reference product both produced the expected reduction in the duration of severe neutropenia in cancer patients undergoing myelosuppressive chemotherapy (1.17 and 1.20 days for Sandoz biosimilar filgrastim and the reference product, respectively). The mean time to absolute neutrophil count recovery in cycle 1 was also similar (1.8 days ± 0.97 in Sandoz biosimilar filgrastim arm vs 1.7 days ± 0.81 in reference product arm). No immunogenicity or antibodies against rhG-CSF were detected throughout the study.

Marketed outside of the US, the Sandoz biosimilar filgrastim is available in more than 60 countries worldwide, has generated over 7.5 million patient-days of exposure and is the most widely used filgrastim in Europe.

Actively involved in the initial stage of the development of recombinant filgrastim was also a mixed team of expert scientists from Lek and the National Institute of Chemistry under the leadership of Doctor Viktor Menart. The team, the majority of its members today employed at Biopharmaceutical Mengeš, was developing a technology for the preparation of recombinant filgrastim, and a part of the innovative technology was transferred into the production of biosimilar filgrastim in Austria. The technology for the preparation of recombinant filgrastim has been successfully established also across the Sandoz group and has been subject to patent applications. The development of the filgrastim pharmaceutical form was also carried out at Lek, a Sandoz company, where the first registration batches of the final filgrastim pharmaceutical form were manufactured and intended for use in Phase I clinical studies. The team of scientists at Biopharmaceuticals Mengeš and the National Institute of Chemistry Ljubljana received in November 2014 the Puh Award, one of the highest state recognitions in the area of scientific and research activities, for the development and production of the biosimilar medicinal products filgrastim and pegfilgrastim and their transfer into production.

Sandoz has a commitment to increasing patient access to high-quality biosimilars. Sandoz is the global market leader with over 50 percent volume share of biosimilars approved in North America, Europe, Japan and Australia. Sandoz currently markets three biosimilars (somatropin, filgrastim and epoetin alfa) outside the US; each of which occupies the #1 biosimilar position in its respective category. The Sandoz pipeline has several biosimilars across the various stages of development, including five programs in Phase III clinical trials/filing preparation – more than any other company in the industry.

About Neutropenia

Neutropenia is a condition characterized by a low amount of neutrophils in your blood – one of the most common types of white blood cells – whose role is to protect the body from infections. Neutropenia occurs often following cancer treatments, as well as advanced HIV infections. Filgrastim is a naturally occurring protein produced commercially by recombinant DNA technology, which stimulates production of white blood cells.

* * *

Lek, a Sandoz company, is one of key pillars of the second-largest generic pharmaceutical company globally. Its role within Sandoz is to act as: a leading global development center for technologically demanding products and technologies; a global manufacturing center for active pharmaceutical ingredients and medicines; a competence center for the development of vertically integrated products; a Sandoz competence center in the field of development and manufacturing of biosimilar products; and, a supply center for the markets of Central and Eastern Europe (CEE), South East Europe (SEE) and Commonwealth of Independent States (CIS), and it is responsible for sales on the Slovenian market. For further information please visit http://www.lek.si/en.

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).
Sandoz is on Twitter. Sign up to follow @Sandoz_global at http://twitter.com/Sandoz_Global.

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and over-the-counter products. Novartis is the only global company with leading positions in these areas. In 2014, the Group achieved net sales of USD 58.0 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 130,000 full-time-equivalent associates. Novartis products are available in more than 180 countries around the world. For more information, please visit www.novartis.com.

* * *

This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.

- end -

For additional information contact:
Katarina Klemenc
Corporate Communications
Lek Pharmaceuticals d. d.
Phone: +386 1 580 22 43
Fax: +386 1 580 24 32