Biosimilar Drug Profile: Releuko is a biosimilar version of filgrastim (reference product, Neupogen, Amgen) manufactured by Kashiv Biosciences and marketed by Amneal Pharmaceuticals, Inc. Reuleuko was originally developed by Adello Biologics (which was acquired by Kashiv). A US biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in September 2017 with approval by the FDA in March 2022 (a complete response letter was likely filed by the FDA in the intervening time). In 2018, Amgen filed a lawsuit claiming patent violations and that Adello failed to follow the necessary biosimilar development protocol outlined by law.
This was the third filgrastim biosimilar approved by the FDA (following Sandoz’s Zarxio® in 2015 and Pfizer’s Nivestym® in 2018). Annual U.S. filgrastim sales in 2021 were $407 million. with $275 million attributed to the two biosimilars.
About the Manufacturer
Kashiv Biosciences LLC is located in Piscataway, New Jersey. Kashiv Pharma was founded in 2011. Kashiv Pharma purchased Adello Biologics in January 2019 to form Kashiv Biosciences. Amneal Pharmaceuticals acquired a 98% interest in Kashiv’s specialty pharmaceutical division in January 2021. This was the first biosimilar to be approved by the FDA for Kashiv and Amneal.
Amneal also has two other approved biosimilars, a pegfilgrastim biosimilar developed with Kashiv, and a bevacizumab biosimilar developed with mAbxience.
News, Commentary, and Intelligence
Competitor Products and Manufacturer Analysis
Approved Products
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 |
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; marketed |
Pegfilgrastim |
|||||
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 |
Pegfilgrastim-bmez |
Ziextenzo |
Neulasta |
December 2015/April 2019 |
FDA Approved November 2019; marketed |
Kashiv/Amneal |
Pegfilgrastim-pbbk |
Fylnetra |
Neulasta |
2021 |
FDA approved May 2022 |
CRL = complete response letter. * Granix was approved under the 505(b)2 pathway, not as a biosimilar. |
|||||
Filgrastim Products in Development
Company |
Product Name |
Stage of Development |
Tanvex Biologics |
TX-01 |
FDA issued a CRL September 25, 2019. At that time the FDA did not request additional clinical data or have any safety concerns. The BLA was resubmitted in November 2020. On May 20, 2021 the company communicated that they received a CRL from the FDA. |
Partners Amneal and Kashiv Score Approval From FDA for Their Pegfilgrastim Biosimilar
(May 31, 2022) On May 27, Amneal Pharmaceuticals announced that the U.S. Food and Drug Administration granted approval to Fylnetra™ (pegfilgrastim-pbbk), a new biosimilar that will launch later this year. This is its third biosimilar approval since January 1.
A Profile on Lesser-Known Player in the Biosimilar Space: Amneal Pharmaceuticals
(March 4, 2022) Amneal received FDA approval for its filgrastim biosimilar (Releuko™) on March 1, and it is awaiting decisions on a pegfilgrastim biosimilar and a bevacizumab biosimilar as well.
Tanvex BioPharma Receives Complete Response Letter on Its Filgrastim Biosimilar Application
(June 9, 2021) On May 20, 2021 Tanvex BioPharma, Inc. issued a press release announcing that the FDA has not approved its 351(k) application for TX01, a biosimilar version of filgrastim. In the announcement, Tanvex cited the FDA’s need to complete manufacturing site inspections, which have been altered by COVID-19 pandemic restrictions.
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.