Neulasta® European Biosimilar Application
Sandoz announced on February 11, 2016 that its Marketing Authorization Application (MAA) for its biosimilar to Amgen’s EU-licensed Neulasta®
(pegfilgrastim) was accepted for review by the European Medicines Agency (EMA).1
This follows the Federal Drug Administration (FDA) acceptance of Sandoz’s 351 (k) abbreviated Biologic License Application (aBLA) for pegfilgrastim fled in November, 2015, which used Amgen’s U.S.-approved Neulasta®
as the reference product.2
Pegfilgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF), indicated to treat chemotherapy side effects in non-myeloid cancer patients; specifically, low white blood cell count (neutropenia) and fever associated with low neutrophil granulocytes counts (febrile neutropenia).
Sandoz is seeking approval for the same indication as Neulasta®
. The U.S. and European applications are supported by three clinical trials – one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients. The filings for pegfilgrastim follow close on the acceptance of Sandoz’s applications for a biosimilar of etanercept in the U.S.3
last year. Infliximab Biosimilar Acquisition
On February 12, 2016, Sandoz also announced the acquisition of PF-06438179, a biosimilar of infliximab, in the 28 countries that form the European Economic Area (EEA).5 Pfizer retains commercialization and manufacturing rights to infliximab in all countries outside of the EEA.
According to the press release, “Sandoz acquired the rights to infliximab, following Pfizer’s commitments to the European Commission in connection with the acquisition of Hospira, Inc. to divest the program.” Infliximab is a tumor necrosis factor alpha (TNF-α) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis. Sandoz will complete the clinical study program and submit the biosimilar infliximab to the EMA for regulatory approval and registration with the European Commission. These activities reflect the increasing pace of biosimilar products moving towards the market, with many market players jostling for market share in the space.6 Download a PDF 1
See Sandoz’s February 11, 2016 press release here
See Sandoz’s November 18, 2015 press release here
See Sandoz’s October 2, 2015 press release here
See Sandoz’s December 8, 2015 press release here
See Sandoz’s February 12, 2016 press release here
See Stanton, D. “Pfizer to be dominant biosimilar developer post Hospira deal,” here
, April 8, 2015 (providing a good outline of biosimilar pipelines by reference product); Stanton, D. “Mylan doubles biosimilar pipeline in $245m Momenta deal,” here
, January 12, 2016 (describing recent partnering deal increasing Mylan’s biosimilar pipeline); Stanton, D. “AbbVie” ‘We have entered a new phase in our biosimilar strategy,” here
, February 2, 2016 (describing market pressures facing AbbVie).