Ziextenzo

Summary: Ziextenzo (LA-EP2006) is a biosimilar version of pegfilgrastim (reference product, Neulasta by Amgen) that is manufactured by Sandoz. A biologic license application for approval via the 351(k) biosimilar pathway was originally submitted to the Food and Drug Administration (FDA) in December 2015, with final approval given in November 2019. Sandoz launched the drug immediately following approval. This agent, like all other biosimilar pegfilgrastim candidates, was subject to complete response letters from the FDA. Its 351(k) application was resubmitted in April 2019. Sandoz set its initial price at a 37% discount in wholesale acquisition cost discount relative to Neulasta.

Sandoz, although established as a division of Novartis in 2003, has its origins as an active player in the pharmaceutical industry in 1886. It has a considerable portfolio of biosimilar products approved by the FDA and in various stages of filing.  Besides Ziextenzo, Sandoz has obtained FDA approvals for Zarxio (filgrastim-sndz), Hyrimoz (adalimumab-adaz), and Erelzi (etanercept-szzs). Sandoz has withdrawn its biosimilar rituximab from consideration for FDA approval (though also approved in the EU).  The company also markets a biosimilar infliximab in the EU.

Ziextenzo is the third pegfilgrastim biosimilar to be approved by the FDA. The product entered the marketplace in November 2019 at a wholesale price slightly below that for competitors Udenyca and Fulphila (37% WAC discount to Neulasta vs. 33% for its competitors).

(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.

(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.

(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.

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