Stockholm, May 12, 2008 – Sandoz today marks a milestone in its efforts to enhance access to affordable, high-quality biopharmaceutical medicines, with the international presentation of clinical safety and efficacy data supporting Binocrit® - the first biosimilar epoetin alfa.

The findings, presented at a Sandoz-sponsored symposium in Stockholm during the XLV European Renal Association / European Dialysis Transplantation Association Congress, clearly demonstrate the safety and efficacy of Binocrit¹, the world’s first complex biosimilar, in anemia treatment using approved administration routes.

In a precedent-setting decision in April 2006, Sandoz was the first company to obtain EU approval for a biosimilar medicine, human growth hormone Omnitrope®. Binocrit was approved in the EU in August 2007 and launched later the same year, confirming the pioneering Sandoz position in this new field. Approval was indicated for use in treating patients with renal anemia as well as those receiving chemotherapy².

The development program for Binocrit, which included major clinical studies, also demonstrated its therapeutic equivalence in the treatment of anemia and provided clinical evidence pivotal to its authorization under the European Medicines Agency (EMEA) biosimilar guidelines³. Binocrit was compared to leading anemia treatment Eprex/Erypo®  (Johnson & Johnson Ortho Biotech).

Professor Huub Schellekens, of the department of medical biotechnology at the University of Utrecht in The Netherlands, reviewed the evidence supporting the EU approval process for medicines such as Binocrit. He said: “The EMEA biosimilar approval pathway is acceptable today – the introduction of biosimilar approval in Europe continues to stimulate research from all sides on structure and function of protein medicines. This is a good thing.”

Professor Nicole Casadevall, of the department of immunology and hematology at Sainte Antoine Hospital in Paris, France, surveyed the management of potential problems with erythropoeisis stimulating agent (ESA) therapy. She concluded that ESAs approved by the biosimilar pathway do not present a “special risk” with regard to adverse events such as pure red cell aplasia.

Professor Stephen Powis of the Royal Free Hospital, London, UK, a renal physician and research specialist, said: “The potential to demonstrate therapeutic equivalence of new versions of ESA approved as biosimilars represents an increased opportunity for treatment for patients, renal physicians and healthcare systems. This scientific symposium provides an educational platform for this new, important and developing area.”

Medicines approved as biosimilars are authorized versions of existing biopharmaceutical medicines, whose patents have expired. They are large complex molecules, such as proteins, and are created with recombinant genetic technology, using living organisms. Their development is dependent on a high level of technology and requires considerable investment.