Sandoz 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®).
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.
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.
As with all its biosimilar development programs, Sandoz has focused on using state-of-the-art 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.