Mylan to Launch Fulphila at 33% Discount to 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.