Fulphila

Biosimilar Drug Profile:  Fulphila (initially designated MYL-1401H) is a biosimilar version of pegfilgrastim (reference product, Neulasta, Amgen) co-developed by Mylan/Biocon. Fulphila is marketed in the US by Mylan. A biologic license application for approval via the 351(k) biosimilar pathway was submitted to the Food and Drug Administration (FDA) in February 2017, with the FDA issuing a Complete Response Letter issued in October 2017. After a resubmission, the biologic was approved by the FDA in June 2018.

Mylan and Biocon initiated a joint venture in 2009 for multiple biosimilar products and insulins. They co-developed the compound. Mylan GmbH will manufacture the biologic and has commercialization rights in the U.S for Fulphila, in addition to Canada, Australia and New Zealand, and the EU. Biocon has manufacturing and commercialization rights elsewhere globally. Mylan is headquartered in Pennsylvania while Biocon has their headquarters in India.

Fulphila was the first pegfilgrastim biosimilar to reach the market. The drug entered the marketplace at a 33% discount to the list price of Neulasta, followed by Coherus’ Udenyca, which matched this discount. Sandoz and Pfizer also have approved pegfilgrastim biosimilars approved in 2018 and 2020, respectively.

Competitor Pegfilgrastim Biosimilars Approved and in Development

(June 11, 2020) Pfizer announced the FDA approval of the fourth biosimilar version of pegfilgrastim. Nyvepria is the latest addition to the Pfizer portfolio of approved biosimilars. .

(May 27, 2020) This marks the first biosimilar application by the manufacturer intended for the US market; a decision is expected in Q2 2021.

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

(January 5, 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. And no, the name is not misspelled here; the name is a close cousin of pegfilgrastim.

(November 15, 2019) 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%.

(August 1, 2019) Coherus BioSciences, in a press release announcing second quarter results, claims 13% of the pegfilgrastim marketplace, forecasting 20% by end of 2019.

(May 30, 2019) Effective July 1, 2019, approximately 22.5 million commercial and 6 million Medicaid UHC members will not be able to access these pegfilgrastim and infliximab biosimilars without trying the reference agents first (virtually eliminating biosimilar use).

(April 8, 2019) Coherus BioSciences is having more success selling its biosimilar version of Amgen’s Neulasta than Wall Street expected.

(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. In addition, the EMA’s Committee for Medicinal Products for Human Use has also recommended approval for three pegfilgrastim biosimilars—from Sandoz, Cinfa, and Mylan.

(July 30, 2018) The first pegfilgrastim biosimilar lgrastim (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^®. This is a watershed moment for the pegfilgrastim category and could signal the beginning of large savings opportunities for payers and patients.

(August 9, 2018) In reporting lower earnings on its second-quarter revenues, Mylan may have surprised industry observers by offering the possibility of some changes in strategic direction.

(June 18, 2018) When the Food and Drug Administration (FDA) approved the first biosimilar pegfilgrastim (Mylan’s Fulphila™), it broke precedent in more ways than one. Not only was this the first biosimilar member of the pegfilgrastim class to be approved, but its approval did not require an FDA Advisory Committee recommendation.

(June 3, 2018) The race to bring a pegfilgrastim biosimilar to market officially started on December 17, 2014. The checkered flag fluttered 3½ years later on June 4, 2018, with the Mylan/Biocon team winning on a slow track.

(May 25, 2018) At a current 62% marketshare for Neulasta Onpro, the initial total slice of the pie available for biosimilars may only be $1.5 billion (not considering WAC discounts).

(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.).

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