On February 18, 2015, Apotex Inc., announced that the Food and Drug Administration (FDA) had accepted its application for a biosimilar version of Amgen Inc’s Neupogen®. Apotex is second to Sandoz Inc. to propose a biosimilar version of Neupogen® (filgrastim), which is administered during chemotherapy to boost white blood cell counts and help fight infections. This is Apotex’s second biosimilar application, following Neulasta® (pelfilgrastim), a long-acting version of Neupogen®, filed last year. The approval of both Sandoz’s and Apotex’s Neuopogen(r) biosimilar applications could shed some light on the extent to which biosimilars will impact biologic sales.
Apotex hopes its biosimilar will be designated as an “interchangeable” product under the Biosimilars Act, which means that pharmacists filling prescriptions for Neupogen(r) could potentially substitute it without consulting the prescribing physician. However, it it is unclear whether it will benefit from the exclusivity period awarded to the first interchangeable product in view of Sandoz’s earlier filed Neupogen(r) biosimilar application. Even though Sandoz has publicly stated that it is not seeking interchangeability status for its Neupogen® biosimilar product, if the FDA nevertheless designates it as interchangeable Apotex would not be entitled to exclusivity for its Neupogen® biosimilar, and would have to wait until Sandoz’s exclusivity expired before the FDA would designate Apotex’s Neupogen® biosimilar as interchangeable. On the other hand, if the FDA does not designate Sandoz’s Neupogen® biosimilar as interchangeable, then Apotex’s biosimilar could be designated as interchangeable, as well as benefit from the exclusivity awarded to the first biosimilar to receive designation as interchangeable.
For more information on this topic, please contact David A. Fazzolare or Joanna T. Brougher.