Summary: Zarxio is a biosimilar version of filgrastim (reference product, Neupogen, Amgen) manufactured and marketed by Sandoz. A biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in May 2014, and it was the first biosimilar approved in the United States on March 6, 2015, launching six months later.
About the Manufacturer
Sandoz, although established as a division of Novartis in 2003, has its origins as an active player in the pharmaceutical industry in 1886. It has a considerable portfolio of biosimilar products approved by the FDA and in various stages of filing. Besides Zarxio, Sandoz has obtained FDA approvals for Hyrimoz (adalimumab-adaz) and Erelzi (etanercept-szzs). Its biosimilar version of pegfilgrastim is awaiting FDA approval (though approved in the EU). Sandoz has withdrawn its biosimilar rituximab from consideration for FDA approval (though also approved in the EU). The company also markets a biosimilar infliximab in the EU.
News, Commentary, and Intelligence
Competitor Products and Manufacturer Analysis
Company |
Product name |
Brand name |
Innovator product |
Filing Date |
Stage of development |
Filgrastim |
|||||
Pfizer |
Filgrastim-aafi |
Nevistym |
Neupogen |
Q4 2017 (est) |
FDA approved July 20, 2018; marketed |
Teva |
Tbo-filgrastim* |
Granix* |
N/A |
2009 |
FDA approved August 30, 2012 |
Kashiv Biosciences |
TBD |
Neupogen |
September 2017 |
FDA decision expected Q3 2018; no FDA action reported (CRL issued?) |
|
Tanvex Biologics |
TX-01 |
TBD |
Neupogen |
October 2018 |
FDA issued CRL September 25, 2019 |
Apotex (Apobiologix) |
TBD |
Neupogen |
February 2015 |
No public information on FDA action (CRL issued?) |
|
Pegfilgrastim |
|||||
Kashiv Biosciences |
TPI-120 |
Neulasta |
Application possible in 2019 |
||
Apotex (Apobiologix) |
Lapelga |
Neulasta |
December 2014 |
No public information on FDA action reported (CRL issued?) |
|
Coherus Biosciences |
Pegfilgrastim-cbqv |
Udenyca |
Neulasta |
August 2016 |
Approved November 2, 2018; marketed |
Mylan/Biocon |
Pegfilgrastim-jmdb |
Fulphila |
Neulasta |
February 16, 2017 |
Approved June 4, 2018; marketed |
Sandoz |
LA-EP2006 |
TBD |
Neulasta |
December 2015 |
CRL issued June/July 2016; withdrew EMA application January 2017; new application filed April 2019 |
| CRL = complete response letter. | |||||
Implications of UnitedHealthcare’s Preference of Remicade and Neulasta to Their Biosimilars
(May 30, 2019) Effective July 1, 2019, approximately 22.5 million commercial and 6 million Medicaid UHC members will not be able to access these biosimilars without trying the reference agents first (virtually eliminating biosimilar use).
An Interview With Doug Long, IQVIA
(February 21, 2019) Doug Long, Vice President of Industry Relations at IQVIA (formerly QuintilesIMS), spoke with us about some of the intracacies of the filgrastim and pegfilgrastim marketplace, and regarding improving access to biosimilars in general.
Biosimilar Maker Adello Biologics Bought by Pharma Research Company
(January 4, 2019) The assets of biosimilar drug developer Adello Biologics were sold to Kashiv Pharma, LLC, the companies announced on January 4, 2019. The new company will now be known as Kashiv Biosciences, with its headquarters in Bridgewater, New Jersey.
An Update From BBCIC: A Conversation With Cate Lockhart, Program Director—Part 2
(October 12, 2018) At the recent AAM meeting, Hillel Cohen from Sandoz said that of 69 adverse drug reports for filgrastim since 2015, all but four were filed without the four-letter suffix, and they were able to identify the correct brand, whether it was Zarxio, Granix, or Neupogen.
Tidal Wave of Pegfilgrastim Biosimilars About to Hit Europe
(September 27, 2018) The European Medicines Agency (EMA) has had an extremely busy week in the pegfilgrastim biosimilars arena, granting marketing authorization to two companies’ products. In addition, the EMA’s Committee for Medicinal Products for Human Use has also recommended aprpoval for three others.
Scaling the Mountains to Create a Biosimilar Market Success
(September 11, 2018) The only biosimilar market success story to date, Zarxio®, may be as much the result of a certain set of preconditions as that of Sandoz’s marketing efforts.
Part B to Part D and Other Questions: How CMS’s Plans Could Affect Biosimilars
(August 10, 2018) Some of these tactics are a bit late to the party, as commercial insurers and health plans have been employing them for years. To the extent that an injectable treatment can be managed through the pharmacy benefit rather than the medical benefit, the drug can be easily subjected to prior authorization, step therapy, quantity limits, and other tools routinely used.
Pfizer Gets FDA’s Green Light on Its Filgrastim Biosimilar
(July 21, 2018) The originator product, Amgen’s Neupogen®, has steep competition from two other products (Sandoz’s Zarxio®[filgrastim-sndz] and Teva’s Granix® (tbo-filgrastim]). Granix was approved as a follow-on biologic, before the biosimilar pathway was implemented.
A Test for Adello and for FDA’s Biosimilar Approval Pathway
(March 29, 2018) Adello Biologic’s 351(k) application for filgrastim comprises the physiochemical biosimilarity evidence, but in terms of clinical data, only phase 1 studies were performed..
Evidence to Support Zarxio Use Presented at AMCP
(October 27, 2017) Two posters presented at the Academy of Managed Care Pharmacy bolstered the case for moving away from the use of the originator filgrastim product Neupogen.
Coverage Uptake: Zarxio Covered by 94% of Employer-Sponsored Plans
(July 11, 2017) An analysis released by Avalere on July 11 showed that coverage of biosimilar filgrastim is the rule, not the exception, by employer-sponsored plans.
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