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    FDA Approves US' First Biosimilar Product, but Regulatory Questions Remain

    The US Food and Drug Administration (FDA) has announced the landmark approval of the US' first biosimilar product, Sandoz' Zarxio (filgrastim-sndz), a drug biologically similar to Amgen's Neupogen. The product is the first to be approved under the 351(k) biosimilar pathway, which was first established under the Patient Protection and Affordable Care Act —Obamacare—in 2010. The approval of Zarxio, which is marketed in several other markets under the brand name Zarzio,...