Company: Amgen and Johnson & Johnson
2017 U.S. sales: $1.77 billion
Competition expected: Unknown
Biosimilars to Amgen's Epogen have been available on the European market for more than a decade, but so far the U.S. biosimilars market has lagged and copycats aren't available. While timing is uncertain due to regulatory stumbles, this might be the year the blockbuster has to face off against a cheaper rival.
Epoetin alfa, marketed by Amgen as Epogen and Johnson & Johnson as Procrit, treats anemia due to chronic kidney disease or cancer treatments. Together, the meds brought in $1.77 billion in U.S. sales last year.
Johnson & Johnson executives have figured their med will see competition and built that assumption into the company's 2018 financial guidance, they said on the company's fourth-quarter conference call. Epogen lost some patents in 2013 and others in 2015, according to Amgen's 10-K.
On the biosim front, Pfizer suffered a regulatory setback with its would-be copycat when the FDA in June 2017 issued a complete response letter over concerns at a manufacturing plant.
The agency didn't ask for new clinical data to support a nod, the company pointed out. Back in 2015, the FDA rejected the biosim and asked for more data, delaying a potential launch for several years.
To Pfizer's advantage, the FDA staff have already found the product nearly identical to Amgen's blockbuster, and an expert committee voted to recommend approval. A Pfizer spokesperson told FiercePharma the company resubmitted the biosim to the FDA in November 2017.
"Pfizer is committed to making this important treatment option available to patients and physicians as quickly as possible," the company's representative said.
Sandoz, for its part, has completed phase 3 trials and launched its biosim in Europe, according to Mizuho analysts. Big Molecule Watch notes that former drug development head Vas Narasimhan, now Novartis' CEO, said on a conference call last year that the company is "continuing to evaluate some additional data that has come in," adding that "once we fully evaluate that data, we’ll clarify our filing strategy on Epo[gen].”
However, the project has been removed from Sandoz' online biosim pipeline.