Nyvepria

Product Profile:

Pegfilgrastim-apgf (Nyvepria)

Drug Category: Granulocyte colony–stimulating factor

Target Indications: Reduce the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Manufactured and marketed by Pfizer

Summary: Nyvepria (HSP-130/PF-06881854) is a biosimilar version of pegfilgrastim (reference product, Neulasta by Amgen) that is manufactured by Pfizer. It is a legacy product of Pfizer’s acquisition of Hospira in 2015. A biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in the third quarter of 2019, with final approval given June 11, 2020. This approval was supported by two phase 1 studies in addition to comprehensive analytical and characterization research. Nyvepria is the fourth pegfilgrastim biosimilar to obtain approval, and it was approved for all of the reference product’s indications. Nyvepria has not yet been launched in the United States.

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 Nyvepria, its approved biosimilars include Inflectra, the first biosimilar version of Remicade; Ixifi, another version of Remicade that will be sold overseas only; Trazimera, a biosimilar trastuzumab; Retacrit, a biosimilar epoetin that was approved in May 2018; Ruxience, a biosimilar rituximab that was approved in July 2018; Zirabev, a biosimilar bevacizumab approved in July 2019; and Nevistym, a biosimilar version of filgrastim that is also marketed. Pfizer’s biosimilar pipeline consists of a biosimilar adalimumab in phase 3 trials.

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

Nyvepria is the fourth pegfilgrastim biosimilar to be approved by the FDA. Pfizer indicated that it would be launched at some point in 2020, without further specification. According to a Bernstein analysis, Amgen’s Neulasta OnPro® holds the dominant marketshare, at 58% in April 2020, followed by Coherus Bioscience’s Udenyca®, at 20%. The first biosimilar approved, Mylan/Bioon’s Fulphila® trails with approximately 6%, and Sandoz’s Ziextenzo® gained slightly less than 1% of the marketshare since its November 2019 launch. The original syringe and vial form of Neulasta continues to lose its share of the market, capturing 15% at the time of Bernstein analysis.

Company name, Country Product name Brand name
Approved     Approval date

Mylan/Biocon

MYL-1401H

Fulphilia

June 2018; marketed

Coherus Biosciences

CHS-1701

Udenyca

November 2018; marketed

Sandoz

LA-EP2006

Ziextenzo

November 2019; marketed

Pfizer

HSP-130

Nyvepria

June 2020; not yet marketed

 

In Development     Stage of Development

Adello (Kashiv Biosciences)                             

TPI-120

 

Application possible in 2020

Fresenius Kabi

MSB11455

TBD

Submitted May 27, 2020. FDA decision expected Q2 2021

Apotex

 N/A

Lapelga

Submitted December 2014. No FDA action reported (Complete response letter likely issued)

Pfizer's Gains Approval of New Pegfilgrastim Biosimliar

(June 11, 2020) Pfizer announced the FDA approval of Nyvepria, the fourth pegfilgrastim biosimilar; launch and marketing slated for later this year, according to a press release.

FDA Accepts New Pegfilgrastim Biosimilar Application From Fresenius Kabi

(May 27, 2020) First US biosimilar filing by Fresenius Kabi is for pegfilgrastim; FDA decision expected Q2 2021.

An Interesting Comparison: The Latest Data on US and EU Biosimilar Uptake

(April 23, 2020) Doug Long at IQVIA characterized Coherus Bioscience’s launch of Udenyca as one of the most successful of 2019.

Sandoz Sets Ziextenzo Price 37% Below WAC for Reference Neulasta

(November 15, 2019) According to reports, Sandoz has set a price of $3,925 for a 6- mg dose of its new pegfilgrastim biosimilar Ziextenzo™. Based on this pricing, the third biosimilar pegfilgrastim will undercut the wholesale acquisition cost (WAC) of Neulasta® by 37%.

More Positive News From Coherus

(November 6, 2019) Coherus Biosciences announced that its marketshare for its lead biosimilar product Udenyca® had reached 19% as of end of the third quarter. The company is hoping to crack 20% by the end of 2019.

Sandoz Gets FDA Approval for Its Pegfilgrastim Biosimilar, Ziextenzo

(November 5, 2019) Sandoz received its long-awaited nod to begin marketing Ziextenzo, the third pegfilgrastim biosimilar. Approved and marketed in Europe in 2018, pegfilgrastim-bmez should be available for prescription by doctors before the end of 2019, according to Sandoz.

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.

More Details on Coherus Bioscience’s Udenyca Launch

(January 8, 2019) At the JP Morgan Investor Conference yesterday in San Francisco, Coherus President Dennis Lanfear outlined what he considers a “full-on branded launch” for the biosimilar maker’s key product.

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.

Coherus Gets FDA Approval for Its Pegfilgrastim Biosimilar

(November 2, 2018)  With the Food and Drug Administration (FDA) approval today of Coherus Bioscience’s Udenyca™ (pegfilgrastim-cbqv), the second pegfilgrastim to compete with Amgen’s Neulasta®, much attention will be now focused on the company’s November 8 earning call.

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. In addition to granting marketing authorization to Coherus Biosciences for its pegfilgrastim biosimilar, it has also approved the marketing of Pelgraz®, a pegfilgrastim produced by Accord Healthcare.

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.

Mylan’s Fulphila Pegfilgrastim Biosimilar Launches at Big Discount

(July 30, 2018) The first pegfilgrastim biosimilar (Fulphila™) in the US has begun marketing, and Mylan/Biocon are offering a 33% discount to the wholesale acquisition cost (WAC) of the originator product Neulasta®.

What Is the Biosimilar Pegfilgrastim Market Opportunity?

(May 25, 2018) This means a US market of approximately $4 billion for one year of sales. Amgen also noted that 62% of its first-quarter Neulasta sales are associated with its Onpro® kit.

Coherus Biosciences Reaffirms Its Pegfilgrastim Biosimilar Hopes

(May 11, 2018) On a quarterly investor call on May 10, Chief Executive Officer Denny Lanfear also related that an approval decision from the European Medicines Agency (EMA) on this product is expected by June 28, 2018.

Sandoz receives EU approval for Erelzi (biosimilar etanercept)

(June 30, 2017) The European Commission (EC) has approved Sandoz’ (a Novartisdivision) Erelzi (biosimilar etanercept) for use in Europe, to treat multiple inflammatory diseases. Erelzi is approved for use in all indications of the reference medicine, Enbrel.

Coherus Readying to Resubmit Its Pegfilgrastim Application

(January 27, 2017) News about Coherus Biosciences has been limited since the Food and Drug Administration (FDA) rejected its initial application for a pegfilgrastim biosimilar last June. However, at this year’s JP Morgan Healthcare Conference in San Francisco, Coherus issued some positive signs of progress.

The FDA Rejects Mylan/Biocon’s Pegfilgrastim; Market Still Awaits a Biosimilar for Neulasta

(October 11, 2017) In the latest blow to those seeking an alternative to Amgen’s Neulasta®, the Food and Drug Administration (FDA) sent a complete response letter to Biocon, citing manufacturing plant deficiencies, in its rejection of their biosimilar pegfilgrastim application.

Pegfilgrastim: 0 for 3 on Biosimilars at FDA

(June 13, 2017) On June 12, Coherus Biosciences received word of the Food and Drug Administration’s (FDA’s) rejection of its biosimilar pegfilgrastim. Manufacturers have now taken 3 swings and misses, striking out in their quest for a biosimilar version of another blockbuster product.

A Nurse's View of Neutropenia

Neutropenic Fever: A Sign of Serious Infection

Clinical Trials of Nyvepria

Published Trial Results

In addition to its supporting data on physiochemical and structural characteristics, Pfizer’s biologic licensing application was supported by two phase 1 clinical data only (in healthy subjects, not patients). A third phase 1/2 open-label trial was conducted, but it was not a comparative study with the reference agent, and will not be described here.

The objectives of these phase 1 trials in healthy volunteers, were to compare the pharmacokinetics (PK), pharmacodynamics (PD), and safety of HSP-130/PF-06881894 with the reference pegfilgrastim product US and EU-licensed Neulasta (manufactured by Amgen).

The first phase 1 trial was an open-label, randomized, crossover study comprising 153 healthy subjects. Each subject (18–65 yr) was administered a single 6-mg dose of the biosimilar or reference product. The researchers’ primary endpoints were fourfold: (1) the relationship between the absolute neutrophil count (ANC) and time postdose (measured by the area under the curve), (2) the maximum observed ANC, (3) area under the serum pegfilgrastim concentration–time curve, and (4) maximum serum pegfilgrastim levels. The objective of the study was to prove the biosimilar yielded outcomes that were within the predefined 90% confidence interval acceptance limits of the reference agent.

The researchers found that the pharmacodynamics and pharmacokinetic parameters assessed were within the accepted predefined limits, concluding that PF-06881894 elicited similar results to the reference agent.

The second phase 1 trial was an open-label, randomized, parallel-group, study (420 subjects total) that analyzed the safety and immunogenicity of several 6-mg doses of the biosimilar compared with that of US-licensed Neulasta. For this investigation, the main endpoint was the percentage of subjects with the presence of anti-pegfilgrastim antibodies at any time after dosing. Based on the results of this trial, the researchers concluded that the biosimilar did not produce any clinically meaningful safety outcomes compared with Neulasta and was determined to be noninferior.

Important Links and Resources

Information About Biosimilars

Patient Assistance Information

US Biosimilar Filings Status

Copyright 2020 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.