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Sandoz Initiates Two More Phase III Biosimilar Trials

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Sandoz has announced that it has initiated two milestone Phase III clinical trials - one for biosimilar filgrastim (Amgen's Neupogen®) in the US market, the other for its global pegfilgrastim development program (Amgen's Neulasta®).

• Phase III clinical study for filgrastim biosimilar (Neupogen®) is expected to support expansion to the US market.

• Phase III study for Sandoz pegfilgrastim (Neulasta®) represents next major step in Sandoz's global biosimilar development program.

• Latest milestones further reinforce Sandoz's commitment to continued global biosimilar leadership, with a total of 8-10 molecules at various stages of development.

The filgrastim study is to evaluate the efficacy and safety of Sandoz's biosimilar filgrastim versus Neupogen® in breast cancer patients eligible for myelosuppressive chemotherapy treatment.

It is expected to support extension of commercialization to the US, the largest global market for biologics.

Sandoz's filgrastim biosimilar is already marketed under the brand name Zarzio® in more than 30 countries outside the United States.

The pegfilgrastim study, which is being conducted in breast cancer patients undergoing myelosuppressive chemotherapy treatment, represents the next major step in the Sandoz global biosimilar development program.

"Sandoz is already the clear global leader in biosimilars overall and in each of our three marketed products, with approximately 50% total segment share in the highly regulated markets of North America, Europe, Japan and Australia", said Sandoz's global head, Jeff George.

George continued, "These two development milestones demonstrate that we also continue our efforts to make good on the longer-term promise of our leading pipeline."

In addition to Zarzio, Sandoz markets biosimilar somatropin (Omnitrope®) and epoetin alfa (Binocrit®) in countries across Europe and elsewhere. Omnitrope is also marketed in the US, under a different approval pathway.

Ameet Mallik, global head of Sandoz Biopharmaceuticals, added: "The start of these two studies represents significant progress for our broad ongoing development program, which includes previously announced late-stage trials for biosimilar rituximab (Roche's Rituxan®). We will work to leverage our strong capabilities and our unique position within Novartis to drive the continued success of our biosimilar pipeline, with eight to 10 molecules at various stages of development."

As with all its biosimilar development programs, Sandoz has focused on using analytical techniques and process development to produce molecules that are highly similar to their reference product, prior to launching tailored clinical programs to generate appropriate supportive data.

Zarzio is already the #1 filgrastim biosimilar worldwide, accepted in multiple markets as the first choice for primary prevention of febrile neutropenia (low white blood cell counts) and rapidly expanding global patient access to this essential biologic.

Pegfilgrastim is a pegylated form of recombinant human granulocyte-colony stimulating factor (G-CSF), or filgrastim, and Amgen's Neulasta® remains the best-selling G-CSF worldwide.

It is the goal of Sandoz to create the #1 overall G-CSF franchise worldwide, with both its daily filgrastim and its once-per-cycle pegfilgrastim as the most-prescribed medicines in their respective areas.