In an email to The Center for Biosimilars®, Mylan confirmed that it will launch its biosimilar pegfilgrastim at a wholesale acquisition cost (WAC) of $4175 per syringe, a price that reflects a 33% discount to the WAC of Amgen’s reference product, Neulasta.
In addition to being the first drug developer to receive FDA approval for a pegfilgrastim biosimilar, Mylan plans to launch its product, the newly approved Fulphila, at a deeper discount to its reference than any other first biosimilar launched in the US marketplace.
In an email to The Center for Biosimilars®, Mylan confirmed that it will launch its biosimilar pegfilgrastim at a wholesale acquisition cost (WAC) of $4175 per syringe, a price that reflects a 33% discount to the WAC of Amgen’s reference product, Neulasta.
Mylan’s strategy of beginning with such a substantial discount may reflect lessons learned from Celltrion and Pfizer’s launch of Inflectra. When the first biosimilar infliximab, referencing Remicade, launched at just a 15% discount to the reference’s WAC (following the example of Sandoz’s filgrastim biosimilar, Zarxio, which launched at a 15% discount to the reference Neupogen’s WAC), it struggled to gain market share.
With both the shallow discount and the reference product sponsor, Johnson & Johnson (J&J), offering incentives to continue to use the reference drug, payers saw little financial reason to undertake a change to the biosimilar. Pfizer has decried J&J’s strategies as anticompetitive in nature, and has filed suit against the Remicade maker. (J&J has countered, however, that Pfizer has not demonstrated the value of its product or a willingness to compete in the marketplace.)
With Inflectra already struggling to gain a foothold in the marketplace, Merck and Samsung Bioepis’ Renflexis, the second infliximab biosimilar to enter the US market, has seen little uptake despite its deeper launch discount of 35%.
Whether Mylan’s choice to offer such a substantial discount for its pegfilgrastim will help to overcome the hurdles of slow US biosimilar uptake remains to be seen, as does Mylan and partner Biocon’s strategy for pricing their other FDA-approved biosimilar, Ogivri, a trastuzumab product referencing Herceptin.
No launch date has been revealed for either of the Mylan—Biocon biosimilars, but the partnership made strides toward an eventual launch this month when it received the European Union’s Good Manufacturing Practice Certification for its biosimilar production plant in Bangalore, India. Manufacturing practices at the site have been called into question numerous times, most recently in May 2018, when the FDA issued a Form 483 related to 7 observations made during a preapproval inspection. In June 2018, Biocon confirmed that it had received an Establishment Inspection Report from the FDA, and that the inspection of the facility is now closed.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Similar Survival, Safety for Bevacizumab Biosimilar vs Originator in Colorectal Cancer
February 8th 2025A retrospective observational study found no significant differences in progression-free survival or safety in patients with colorectal cancers in Japan treated with ABP 215, Amgen’s bevacizumab biosimilar, or reference bevacizumab (Avastin), and estimated cost savings of 800,000 Japanese yen (approximately $5100) per patient with the biosimilar.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.