- Mylan N.V. used an investor day on April 11 to tout its efforts to broaden its reputation beyond cheap, copycat drugs and move past controversy sparked by steep price hikes on the company's EpiPen product.
- The future, Mylan bets, will be in complex drugs like EpiPen and biosimilars. In these areas, Mylan expects to be just one of a few companies that make such medicines, company CEO Heather Bresch told investors at the event.
- No one drug makes up more than 4% of Mylan's current sales mix — a fact several Mylan execs highlighted during the four-hour event. Product mix and brand "durability" are two goals pushed by the company.
Earlier this week, Mylan announced three deals to bolster its goals of being a leader in hard-to-copy drugs. The company claims complex products already make up 70% of its pipeline value.
The first was a deal with Israel's Mapi Pharma for a once-monthly version of glatiramer acetate, a copy of Teva Pharmaceutical Industries Ltd.'s blockbuster multiple sclerosis drug Copaxone. Mylan has already won approvals of copies of both 20 mg and 40 mg doses of Copaxone. Still, it will work with regulators to plan a Phase 3 trial for Mapi's longer-acting experimental drug.
That deal was followed by a partnership with Fujifilm Kyowa Kirin Biologics Co. Ltd. to commercialize a biosimilar of AbbVie's blockbuster Humira (adalimumab). As the best-selling drug in the world, Humira is the most attractive biosimilar market opportunity out there. Should barriers to biosimilars in the U.S. ease, adalimumab would become a top copycat drug to sell for biosimilar developers.
So far, AbbVie expects to stave off any copycats until at least 2022 in the U.S. But Mylan, at least at this point, aims to commercialize the Humira biosimilar in Europe, where market exclusivity for the branded drug ends in October.
The company has 16 biosimilars and insulin analogs in development or on market already and it expects to launch a Neulasta biosimilar in June.
"As far as biosimilars. I've given a lot of thought to this. There are a lot of parallels to the small molecule evolution and how Hatch-Waxman evolved in 1984," said Bresch, who noted that generics have a 90% share of the small molecule drug market. While Bresch doesn't believe it will take as long as a decade for biosimilars to make a dent in the U.S. market like small molecule generics did, she admits she doesn't believe biosimilars will gain 90% market share.
Instead, Mylan expects the growth curve for biosimilars to be lower, slower and more durable.
"On the macro sense, the scale and size of the biologics market is so large and you see the growth. So if you are not investing in these [biosimilars] then you are missing the generics opportunity," added Chief Commercial Officer Tony Mauro.
"There's no question that there are different dynamics at play in the brand/biologics/biosimilars space ... but from our perspective, that even if they still hold 50% market share, there's still 50% share," added Bresch. Due to the limited number of companies in the space that have put in significant investment, that will net a significant reward, said the CEO, defending the company's decision to go all-in on the copycat generics.
"I think this is going to be a process. These are big products and people have a lot at stake," said Bresch.