Udenyca

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.

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.

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.

(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.

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

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

(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.

(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%.

(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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