- Pfizer on Wednesday announced the U.S. launch of its third biosimilar product, creating a new market threat to Amgen's Epogen and Johnson & Johnson's Procrit.
- Retacrit, a copycat of both Epogen and Procrit, gained Food and Drug Administration approval in May as a treatment for anemia resulting from either chronic kidney disease, an HIV therapy called zidovudine or concomitant myelosuppressive chemotherapy. Initial shipments of the drug went out to U.S. wholesalers on Nov. 12, according to a statement from Pfizer.
- The big pharma set Retacrit's wholesale acquisition cost at $11.03 per 1,000 units/mL, which is 57.1% lower than Procrit's $25.72 per 1,000 units/mL list price and 33.5% lower than Epogen's $16.58 per 1,000 units/mL.
Biosimilars haven't had much success breaking into the U.S. market due to the formidable walls of patent protections and lawsuits set up by reference product makers. AbbVie, for instance, recently staved off a sixth copycat to its mega-blockbuster biologic Humira (adalimumab) — meaning it likely won't see any such competition until 2023.
Amgen has also used courts to its advantage. In 2015, it sued Pfizer subsidiary Hospira for infringing on a couple manufacturing patents related to Epogen (epoetin alfa). Two years later, a jury would conclude that Pfizer was in violation of one of those patents and award Amgen $70 million in damages.
Those weren't the only troubles facing Pfizer and Hospira. Retacrit (epoetin alfa-epbx) received FDA complete response letters in 2015 and 2017, the latter of which resulted from manufacturing violations at a Hospira plant in McPherson, Kansas.
The drug's outlook started to get rosier in spring 2018, however, as it secured FDA approval.
It's now launching into a competitive yet lucrative arena. Epogen and Procrit each raked in around $1 billion last year for their respective developers. But while J&J recorded year-over-year gains for Procrit/Eprex in the third quarter, Amgen has been seeing Epogen sales fall amid a decrease in net selling price.
"With the potential launch of a biosimilar in the U.S. we would expect a further decline in that selling price," Amgen's Executive Vice President of Global Commercial Operations, Murdo Gordon, said on the company's third quarter earnings call.
In a Nov. 14 statement, Pfizer noted that the Centers for Medicare and Medicaid Services granted two unique assigned Q codes for Retacrit, including one for end-stage renal disease patients. The Center for Biosimilars also reported last month that UnitedHealthcare listed Retacrit for 2019 preferred coverage.