What Does Zarxio Launch Mean for the Future of Biosimilar Drugs?

novartis_3Last month, Novartis kicked off a new era in U.S. medicine, launching Zarxio, a biosimilar copy of Neupogen–Amgen’s white blood cell-boosting drug. Zarxio is the first biosimilar copy of a biotechnology drug approved in the U.S. and is being offered at a 15 percent discount to the original.

According to Sandoz, Novartis’ generics unit, Zarxio is a “high-quality, more affordable version” of Neupogen. Amgen had tried to stop the sale of the new drug, but the Washington-based appeals court rejected the U.S. biotech group’s attempt. Investors are now focused on the potential for other companies to produce discounted biosimilars.

Zintro expert Thomas Argentieri is the CEO of BioSense Solutions, LLC, a scientific evaluation, writing and licensing consultancy. He has extensive experience in Drug Discovery and Development, and Licensing and Business Development.

“The question is, what will be Amgen’s next move?” says Argentieri. “Experts expect that Amgen will lower the price of Neupogen to the point where Sandoz’s Zarxio may not be competitive. The biosimilar approval guidelines as currently written require a demonstration not only of safety and bioequivalence but also efficacy. Manufacturing processes are expensive and complicated, and the pharmacist will not be able to substitute the biosimilar for the original product the way generic drug substitution occurs –a new prescription from a physician and presumably a patient office visit will be required.

“Prescribers may also be wary about biosimilars and not automatically assume they have the same safety profile. For example, pure red cell aplasia (PRCA) was associated with Eprex, an erythropoietin alfa used to stimulate the production of red cells in patients with chronic renal failure or undergoing chemotherapy. It became clear that PRCA cases increased dramatically after the removal of human serum albumin from the original epoetin alfa formulation and its replacement with polysorbate 80 and glycine as stabilisers. Despite being deemed biosimilar, such side-effects may only be recognized following several years of post-marketing surveillance – another expense that needs to be factored into the biosimilars equation.

“Knowing all this therefore, will a company sponsoring a biosimilar–with development costs that may exceed $100 million, that cannot be substituted by the pharmacist, that has no long-term safety profile–be able to compete with the originator company who has most likely recouped their development costs and streamlined their manufacturing processes? A company who mostly likely sits on years of safety and efficacy data, and who in all likelihood will dramatically lower pricing? Time will tell.”

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