With an FDA approval for Fulphila, the first U.S. biosimilar to Amgen's Neulasta, Mylan will have its chance to launch a biosim to one of the biggest drug targets in the U.S. market.
It's good news for Mylan, which sees biosimilars as a rescue from the tough market for typical generic drugs. Not so good for Amgen, which reaped $3.9 billion from Neulasta in the U.S. last year and already faces biosimilar competition for the shorter-acting version, Neupogen.
Announcing its FDA approval late Monday, Mylan said it will launch the Neulasta copycat, now dubbed Fulphila, in the coming weeks. The company didn't immediately disclose pricing. A white blood cell booster for cancer patients after chemotherapy, Neulasta brought in $3.9 billion in the U.S. last year, making it the second-largest loss of exclusivity in pharma this year.
That level of sales also makes it a big target for Mylan. In a video discussing the Fulphila approval, Bernstein analyst Ronny Gal predicted the biosim would bring in $100 million this year. Leerink Partners analysts figure on $73 million in Fulphila sales this year and $260 million next year.
"We think the market will gradually adopt biosimilar Neulasta," Gal said. The analyst said he expects Mylan's Fulphila to enter the market at a "much lower price" than that of Neulasta.
Along with other makers of generic drugs, Mylan has been squeezed by U.S. pricing pressure in recent years, but the company has turned to biosims and complex generics to lift its fortunes. At the same time, the federal government is working to boost biosim uptake as a way to create drug savings. Mylan CEO Heather Bresch said in a statement that the FDA "approval of this product, as well as the agency's continued focus on biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients."
Neulasta's "final material U.S. patent" expired in 2015, Amgen reported earlier this year. Coherus, a rival biosimilar developer, has a knockoff under review now, with an FDA decision expected later this year. Behind these first two biosim players, a delay of new entrants is expected, Leerink noted; Mylan and Coherus could hold the market through "at least 2020," they wrote in a note to clients.
Mylan's Neulasta biosim effort ran into a speed bump last October when the FDA issued a complete response letter over manufacturing concerns. Mylan responded, and in January at the J.P. Morgan Healthcare Conference, company president Rajiv Malik said the program could represent a mid-2018 launch opportunity—a prediction that obviously bore out.
Mylan is launching despite a lawsuit from Amgen alleging infringement on two manufacturing patents, according to Leerink. But the analysts wrote that they view the patents as "weak," and they aren't surprised to see Mylan go ahead and launch despite the risk.
Aside from Neulasta, Amgen also faces potential 2018 competition on calcium reducer Sensipar, and another of its major blockbusters could soon face a head-to-head biosim, too. The FDA recently approved an Epogen knockoff from Pfizer, which said it plans to launch this year. Both bring in blockbuster-level sales in the U.S.
On the flip side, the company just won approval for the first in a new class of migraine drugs with Aimovig. Analysts predict the drug, the first approved to prevent migraine attacks, can generate $1.2 billion by 2022.
Mylan is marketing Fulphila under a partnership with India's Biocon, which will manufacture it. The companies previously won FDA approval for a copycat of Roche's Herceptin but haven't launched because of patent litigation. Also this week, the partners received an FDA Complete Response Letter for their biosim to Sanofi's Lantus.