- Mylan and Biocon expect to launch their Neulasta biosimilar on the U.S. market in the "coming weeks," now that the copycat treatment has secured approval from regulators.
- The Food and Drug Administration OK'd Amgen's Neulasta in 2002 to reduce the incidence of infection for patients with non-myeloid malignancies who were taking myelosuppresive anti-cancer drugs — and therefore at risk of having lower white blood cell counts. Mylan and Biocon's offering carries the same indication, and will come to market under the brand name Fulphila.
- Sales of Amgen's original drug have ticked down in the last few years mostly due to lower unit demand outside the states. Analysts expect the new approval will put those sales in a more precarious spot, with some estimating that Mylan and Biocon's copycat could fetch $100 million in U.S. sales by the end of 2018.
Amgen bears a complicated relationship with biosimilars.
On the one hand, the California-based pharma touts a biosimilars unit that is hard at work trying to bring versions of blockbuster products like Rituxan (rituximab) and Remicade (infliximab) to market.
"While gaining regulatory approval of biosimilars has proven challenging for many in the field, we have successfully executed in our plans, receiving first cycle approvals for Amgevita and Mvasi, a biosimilar to Avastin," CEO Bob Bradway said during the company's first quarter earnings call.
But on the other, copycat biologics have brought increased competition to Amgen's doorstep. Novartis, for instance, locked down FDA approval for its biosimilar to Amgen's Neupogen (filgrastim) back in 2015. And now, another top-selling Amgen drug is under threat thanks to Mylan and Biocon.
Investment bank Cowen & Co. projects that Fulphila sales could grow to at least $300 million in 2019. While Coherus Biosciences is also poised to bring a Neulasta biosimilar to market soon, analyst Ken Cacciatore acknowledged that sales of Mylan and Biocon's version will likely be quite durable.
"Even with increased competition, given the size of the branded opportunity this product should still be a nice solid contributor for Mylan for an extended period of time. Other competitors continue to work on the formulation as well, but we do believe that the complexities of the product could leave this to a relatively attractive market for only Mylan and Coherus," Cacciatore wrote in a June 5 note.
In a separate note, Mizuho analyst Salim Syed highlighted that the first area where Fulphila may eat away at Neulasta sales is in the 340B federal program.
Syed pointed to slides Coherus presented at the J.P. Morgan Healthcare Conference in January, which explained that about 29% of Neulasta's gross U.S. sales come from the 340B hospital setting — wherein biosimilars get reimbursed at their annual sales price (ASP) plus 6% for two to three years, while originator products get reimbursed at ASP minus 22.5%. (Amgen clarified to Mizuho that around 35% of Neulasta's U.S. gross sales come from Medicare/Medicaid).
"The reimbursement mechanism for newly approved biosimilars is not fully appreciated by the Street in our view and [Amgen] consensus numbers seems to be modelling this dynamic wrong as a result," Syed wrote.
"The way the math works out, 2018 [earnings per share] could move down about 2% or 25 cents vs consensus. It doesn't create a risk to the 2018 guide if it does ... but nudges the EPS number slightly lower."