Biosimilar Drug Profile: Nivestym is a biosimilar version of filgrastim (reference product, Neupogen, Amgen) manufactured and marketed by Pfizer. Originally designated PF-06881893, this biosimilar was first developed by Hospira (which was subsequently acquired by Pfizer) and approved in Europe in 2010. A US biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in Q4 2017, and it was approved in the US on July 20, 2018. Nivestym was the second filgrastim biosimilar approved and marketed in the US.
About the Manufacturer
Pfizer entered the biosimilar market through two avenues: (1) its acquisition of Hospira and (2) its own internal pipeline development. Pfizer was established in 1849, and it is headquartered in New York City. It has a considerable portfolio of biosimilar products approved by the FDA and in various stages of filing. In addition to Nivestym, its approved biosimilars include Inflectra, the first biosimilar version of Remicade; Ixifi, another version of Remicade that will be sold overseas only; and Retacrit, a biosimilar epoetin that was approved in May 2018. Pfizer’s biosimilar pipeline consists of a biosimilar trastuzumab, bevacizumab, and rituximab, all being filed for approval with the FDA; biosimilar adalimumab in phase 3 trials; and biosimilar pegfilgrastim in phase 1 development.
News, Commentary, and Intelligence
Competitor Products and Manufacturer Analysis
Company |
Product name |
Brand name |
Innovator product |
Filing Date |
Stage of development |
Filgrastim |
|||||
Sandoz |
Filgrastim-sndz |
Zarxio |
Neupogen |
May 2014 |
FDA approved March 6, 2015; 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 (assume 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 Bioscience |
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 |
| *Filed as a 351a product (prior to implementation of 351[k] pathway). Not technically a biosimilar. CRL = complete response letter. | |||||
Sandoz Resubmits Its Pegfilgrastim Biosimilar Application
(April 3, 2019) Sandoz may be chomping at the bit to market its long-delayed pegfilgrastim biosimilar. First rejected by the Food and Drug Administration (FDA) in 2016, the manufacturer of Zarxio® (filgrastim) has completed its 351(k) biosimilar resubmission for its pegylated filgrastim agent.
A Conversation 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 Bought, Now Kashiv Biosciences
(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.
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 approval 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) On July 20, the US Food and Drug Administration (FDA) approved the second biosimilar version of filgrastim. Pfizer’s filgrastim biosimilar is named Nivestym™(filgrastim-aafi).
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.
Copyright 2021 by SM Health Communications. All rights reserved.
We are pleased to hear your questions or comments, which should be provided through our contact us page.