2016 and 2017 were difficult years for companies trying to win US Food and Drug Administration (FDA) approval for biosimilars of Amgen's blockbuster for treating side effects from chemotherapy.
Last June, Coherus Biosciences received a complete response letter (CRL) for its biosimilar of Neulasta (pegfilgrastim), with FDA requesting "a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing related process information."
Similarly, last October, Biocon and Mylan received a CRL for their Neulasta biosimilar, "pending update of the BLA [biologics license application] with certain CMC [chemistry, manufacturing and controls] data from facility requalification activities post recent plant modifications." And Novartis subsidiary Sandoz, meanwhile, received a CRL from FDA in 2016 for its biosimilar.
But competitors are likely to break down Neulasta's monopoly door in 2018 to vie for a slice of a market that's been around since the treatment was first approved by FDA in 2002. Neulasta earned its blockbuster status several times over, bringing in more than $20 billion in sales in just the last five years.
Mylan is expected to lead the way as a spokesman told Focus that it expects to win approval for its biosimilar in 2018.
Coherus said in an SEC filing that it has scheduled a type 2 meeting with FDA in the middle of the first quarter of 2018. Coherus anticipates filing its BLA after receipt of meeting minutes from FDA and completing certain clinical sample analyses, though it said at the JP Morgan conference that it expects "up to 6-month review after resubmission."
Meanwhile, two other Neulasta biosimilar developers, Sandoz and Apotex, have other competitors coming. Apotex said it does not comment on pending filings, and Sandoz has said it will refile its BLA in 2019 after additional clinical studies.
340B Change Implications
And though Amgen has said it believes an increase in competition for Neulasta will come slowly, Bernstein biotech analyst Ronny Gal noted in an investor note some comments discussed by Coherus at JP Morgan's biotech conference earlier this month.
New changes coming to the Centers for Medicare and Medicaid Services' (CMS) drug discount program, known as 340B, would allow new biosimilars to be reimbursed at the average sales price (ASP) plus 6%, whereas originator biologics would be reimbursed at ASP minus 22.5% for between two and three years, according to Coherus' presentation at JP Morgan.
That change could mean Amgen will lose a large chunk of its Neulasta sales quickly.
"Per Coherus, the 340B market is 29% of Neulasta volume," Gal wrote. "However, the pricing is heavily discounted - we calculate ~64% discount to its J-code broader market price. Thus, the financial exposure is ~13% of Neulasta US sales of ~ $3.85B or ~$500M…Amgen investors should be prepared the majority of the $500M of 340B revenue will be lost relatively quickly on launch."
Amgen did not respond to a request for comment.