Product Profile:

Pegfilgrastim-cbqv (Udenyca)

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 Coherus Biosciences

Summary: Udenyca (CHS-1701) is a biosimilar version of pegfilgrastim (reference product, Neulasta by Amgen) that is manufactured by Coherus Biosciences. A biologic license application for approval via the 351(k) biosimilar pathway was originally submitted to the Food and Drug Administration (FDA) in August 2016, with final approval given in November 2018.  This was one of the first biosimilar agents approved by the FDA based on its physiochemical and structural evidence but on phase 1 clinical trial data only. The biosimilar was launched January 2019 at an initial wholesale acquisition cost discount of 33% to Neulasta.

About the Manufacturer

Coherus Biosciences started in 2010 as a biosimilar-only manufacturer, which has since expanded its interests into nonbiosimilar oncology products as well. Coherus Biosciences is also working with partners to bring biosimilars of ranibizumab and bevacizumab to the US market, The company’s sole approved product, a biosimilar of pegfilgrastim, is also approved in the EU.  This agent, Udenyca, has supported the company’s other developmental activities.

News, Commentary, and Intelligence

Competitor Products and Manufacturer Analysis

Udenyca is the second pegfilgrastim biosimilar to be approved by the FDA. The product entered the marketplace in January 2019 at a wholesale price equal to that for Mylan’s Fulphila.

Company name, Country Product name Brand name
Approved     Approval date




June 2018; marketed

Coherus Biosciences



November 2018; marketed




November 2019; marketed




June 2020; not yet marketed 

In Development     Stage of Development

Adello (Kashiv Biosciences)                             



Application possible in 2020

Fresenius Kabi



Submitted May 27, 2020. FDA decision expected Q2 2021




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

Pfizer's Nyvepria Approved by the FDA

(June 11, 2020) Pfizer announced today the FDA approval of its new pegfilgrastim biosimilar. Dubbed Nyvepria, the agent will be marketed later this year, according to a Pfizer press release.

FDA Accepts for Review MSB11455, a Biosimilar Candidate of Pegfilgrastim

(May 27, 2020) This biologic licensing application represents Fresenius Kabi’s first biosimilar candidate submitted to the FDA. for the US market.

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

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

And Now for Something Completely Different… Eflapegrastim vs. Pegfilgrastim

(January 2, 2020) On January 2, 2020, Spectrum Pharmaceuticals announced that the FDA had accepted its 351(a) application for a novel granulocyte colony-stimulating factor (G-CSF), eflapegrastim.

Sandoz Sets Ziextenzo Price 37% Below WAC for Reference Neulasta

(November 15, 2020) Sandoz has set a price of $3,925 for a 6-mg dose of its newly launched pegfilgrastim biosimilar Ziextenzo™. Based on this pricing, the third biosimilar pegfilgrastim will undercut the wholesale acquisition cost (WAC) of Neulasta® by 37%.

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.

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 Udenyca

Published Trial Results

In addition to its supporting data on physiochemical and structural characteristics, Coherus’ biologic licensing application was supported by phase 1 clinical data only (in healthy subjects, not patients). Three phase 1 trials were conducted, two are described here.

The objectives of this phase 1 trial, published in abstract form only, in healthy volunteers, was to compare the pharmacokinetics (PK), pharmacodynamics (PD), and safety of CHS-1701 with the reference pegfilgrastim product Neulasta (manufactured by Amgen).

In this trial, a single-blind, randomized, crossover study, 122 healthy volunteers were randomized to one of three treatment periods: a 6-mg dose of CHS-1701 and two 6-mg doses of Neulasta. Each treatment period was separated by a washout period of at least 28 days.

Bioequivalence was demonstrated if the 90% confidence interval (CI) for the geometric mean ratio (GMR) of CHS-1701 to pegfilgrastim was within 80-125% for primary endpoints: area under the plasma concentration–time curve from 0 to infinity (AUC0-∞) and maximum concentration (Cmax) for pharmacokinetics (PK) and maximum absolute neutrophil count (ANCmax) and ANC area under the curve (ANC AUCs) in terms of pharmacodynamics (PD). Baseline characteristics were comparable between treatment groups (median age, 29.5 yr; age range, 18–45 yr).

The researchers reported that PK bioequivalence criteria were met for Cmax (GMR = 105.0; 90% CI, 95.5–115.4) and AUC0–∞ (GMR = 97.5; 90% CI, 88.6–107.2). PD bioequivalence criteria were met for ANCmax (GMR = 99.6; 90% CI, 96.2–103.2), ANC AUC0–last (GMR = 96.7; 90% CI: 92.2, 101.4), and ANC AUC0–480 (GMR = 99.8; 90% CI, 97.7–102.0). Adverse events were reported in 76.0%, 76.6%, and 73.1% of subjects during the CHS-1701, first pegfilgrastim, and second pegfilgrastim dosing periods across treatment sequences, respectively. Treatment-related AEs occurred in 71.9%, 71.2%, and 62.8% of subjects, respectively. The most common included back pain (33.3%–47.9%) and headache (33.3%–41.4%). There were no serious AEs related to the treatment. No differences in AEs among groups were considered statistically significant.

This study demonstrated the bioequivalence of the biosimilar agent to Neulasta. There were no unexpected safety findings, and the two treatments displayed similar safety profiles.

Another trial (unpublished) was conducted in a randomized, double-blind fashion and included a crossover period. All 116 subjects received one 6-mg subcutaneous injection of CHS-1701 or Neulasta. They were randomized to one of two treatment sequences: Neulasta in the first period and CHS-1701 in the second period, or vice versa.

The study results were not published for this investigation. According to Coherus, the study met its primary PD endpoint of absolute neutrophil count (ANC). In terms of PK parameters, the study also met the criteria for bioequivalence for maximum plasma concentration. Interestingly, the PK profile in the period 1 Neulasta group was low (below that of previous studies), which complicated the comparison for the area under the plasma concentration–time curve (AUC).

The safety profiles of the biosimilar and reference product were determined to be equivalent, and none of the healthy volunteers were found to have neutralizing drug antibodies.

Coherus carried out a separate phase I trial of 207 healthy participants that utilized a triple crossover design. The Figures demonstrate that CHS-1701 (Udenyca) was found to be comparable with Neulasta in terms of PD and PK.

Another phase 1 study was undertaken and completed in 2015 to compare the immunogenicity of its biosimilar with that of the reference product. The results of this investigation are unpublished.

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