- The European Commission approved a fifth biosimilar that will compete with AbbVie's mega-blockbuster biologic Humira, generic drugmaker Mylan said Wednesday. Mylan's Hulio snagged an OK for all of Humira's indications.
- European biosimilar competition is expected to hit AbbVie in less than a month, when its composition-of-matter patent expires in the EU this October.
- While a robust market for the copycat biologics has developed in Europe, the U.S. has lagged as patent hurdles slow down biosimilar launches. Settlement deals cut by AbbVie have pushed off market entry in the U.S. to 2023.
The top-selling Humira (adalimumab) franchise faces the end of its monopoly in Europe next month.
Mylan, in partnership with Fujifilm Kyowa Kirin Biologics, said it plans to launch its Humira copycat "on or after Oct. 16." Mylan has a sublicense agreement with the Japanese company, which owns a non-exclusive royalty bearing license from AbbVie.
In addition to those three companies, Germany's Boehringer Ingelheim and Novartis' Sandoz also have EU-approved biosimilars. Neither indicated launch dates in their approval statements. Boehringer Ingelheim's got the European Commission's OK in November 2017 and Sandoz's was approved in July 2018.
Humira's European revenues are poised to slip after the entry of generics, although questions remain about how hard and fast the fall could be. Most of the TNF inhibitor's profit is made in the U.S., which looks set to remain AbbVie's exclusive domain for several more years.
Judging by recent sales, the U.S. market is roughly three times larger than Europe for Humira.
In the 12 months since the end of June 2018, Humira posted sales of $4.4 billion in Europe, according to IQVIA data reported by Reuters. In that same time frame, the U.S. accounted for $13 billion of Humira's $19.5 billion in worldwide sales, per company filings with the Securities and Exchange Commission.
The American market is set to remain AbbVie's until 2023. Even though its composition-of-matter patent expired December 2016 in the U.S., AbbVie has stronger surrounding patents stateside than in Europe, giving them more layers of defense on the biologic's exclusivity.
Several Humira copycats have been approved by the Food and Drug Administration, but their manufacturers have either reached deals or are tied up in court with AbbVie. Amgen is poised to be the first to market on Jan. 31, 2023, followed by Samsung Bioepis six months later and then Mylan a month after that.
Yet for AbbVie, imminent European biosimilars may not even be its most pressing Humira problem.
Just two days ago, the California insurance commissioner sued the pharmaceutical giant, claiming the company gave illegal kickbacks in cash and gifts to prescribers of Humira — allegations that AbbVie has denied.
Those charges amounted to the largest health insurance fraud case in the department's history, the insurance office said.
Back in July, AbbVie CEO Richard Gonzalez gave a seemingly untroubled vote of confidence to investors in a second quarter earnings call, banking on Humira's continued profitability.
"Every year since I can remember, there has been fretting about Humira," Gonzalez said on the July 27 call. "We have beat every single one of those expectations along the way."
On biosimilars in Europe, Gonzalez was particularly confident that AbbVie has properly accounted for them, at the time saying there was "nothing different from what we anticipated."