Fylnetra

Biosimilar Drug Profile: Fylnetra also known as TPI-120 is a biosimilar version of pegfilgrastim (reference product, Neulasta by Amgen). A biologic license application for approval via the 351(k) pathway was submitted to the Food and Drug Administration (FDA) in August 2020. A resubmission was made November 29, 2021 following a CRL issued August 11, 2021 by the FDA. The product was approved on May 27, 2022.  Fylnetra is the fifth pegfilgrastim biosimilar to be approved by the FDA. The other four pegfilgrastim biosimilars are: Fulphilia (pegfilgrastim-jmbd, Mylan/Biocon); Udenyca (pegfilgrastim-dbqv, Coherus Biosciences); Ziextenzo (pegfilgrasim-bmez, Sandoz); and Nyvepria (pefilgrastim-apgf, Pfizer).  For the 12 months ending in March 2022, US annual sales for pegfilgrastim were $3.1 billion, with $1 billion being from biosimilar products.

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 second biosimilar to be approved by the FDA for Kashiv and Amneal. Reuleuko, a biosimilar of filgrastim, was approved in March 2022.

Amneal, located in Bridgewater, NJ, also has a bevacizumab biosimilar in the pipeline, developed with mAbxience. Amneal’s specialty division has products focused on the central nervous system and endocrine disorders as well as products that address unmet needs.

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.

(May 27, 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.

(May 11, 2022) Coherus Biosciences thinks it will be able to amp up its Udenyca^® sales in 2023, by introducing a competitor on-body injector to Neulasta OnPro^®.

(June 8, 2021) Mumbai, India-based Lupin Ltd is attempting to enter the US biosimilar market for the first time with its version of pegfilgrastim. First approved and marketed in India in 2015, Lupin’s pegfilgrastim application was accepted on June 2 by the Food and Drug Administration.

(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.

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

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

(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%.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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.

(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^®.

(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.

(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.

(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.

(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.

(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.

(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.

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.