This month, the FDA approved the first biosimilar drug in the US—Novartis’s Zarxio. An approximate copy of Amgen’s biologic drug Neupogen for increasing the white-blood-cell counts of cancer patients, Zarxio’s approval for all of Neupogen’s uses leads the way for competition and lower prices for biologics in the US. With the FDA now authorized to approve biosimilars, the drugs, which are expected to be cheaper than the biologics they copy, may increase the accessibility of therapies. Rand estimates that biosimilars will cut drug prices 10%–50%. Several other biosimilars are being developed for use in the US, including five more by Novartis. The FDA does not yet have a policy for naming them, but in the interim will name biosimilars the active ingredient of the drug they copy along with a qualifier (e.g., filigrastime-sndz for Zarxio). The FDA has not yet provided guidance on determining interchangeability of biosimilars with the copied drugs. Novartis will not begin selling Zarxio until either a court decision on a lawsuit filed by Amgen or April 10, whichever is sooner.

Source: Bloomberg Business

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