Merck ($MRK) may trail the first movers in the coming onslaught of blockbuster biosimilars, but the pharma giant is heralding a crop of late-stage copycat treatments it believes can snag a share of the soon-to-boom market.
Presenting at this week's Cowen Healthcare Conference, Merck highlighted 5 knockoffs of top-selling biotech drugs slated for global submissions this year and the next, targeting reference products that gross more than $30 billion combined. Thanks to a 2013 agreement with Samsung Bioepis--a joint venture between the South Korean giant and Biogen Idec ($BIIB)--Merck has the marketing rights to a slew of biosimilar candidates while its partners handle R&D.
Leading the way are copies of AbbVie's ($ABBV) Humira, Johnson & Johnson's ($JNJ) Remicade and Amgen's ($AMGN) Enbrel, which Merck expects to file for approval this year or in early 2016, the company said. Same goes for its take on Sanofi's ($SNY) blockbuster insulin Lantus, and Merck also has the rights to a copy of Roche's ($RHHBY) cancer treatment Herceptin, which it plans to submit next year.
And despite lagging behind Novartis ($NVS), Celltrion and other early leaders in biosimilars, Merck is confident its decades of commercial experience will allow it to quickly catch up on the global marketplace. The Samsung deal was designed to maximize each party's best attributes, Merck Global Human Health President Adam Schechter said at the Cowen conference, leaving development and manufacturing to the Korean company and allowing Merck to flex its marketing muscles.
"These are areas that we know very well," Schechter said. "Diabetes, anti-TNF, oncology--we know how to be successful in those areas and we have portfolio products in those areas."
But Merck will have to navigate a bramble of licensing deals and intellectual property issues on its way to biosimilar profits. Due to existing agreements, the company will have to limit its sales of Humira and Remicade to countries outside the EU, Russia and Turkey, and its spin on Enbrel is ineligible for launch in the U.S. EU and Japan, limiting its sales potential.
Meanwhile, the long-expected arrival of copycat biologic blockbusters is rapidly becoming a reality, as worldwide sales for biosimilars are projected reach $35 billion by 2020 after scraping together just $1.3 billion in 2013.
Last month, partners Celltrion and Hospira ($HSP) made European landfall with their version of Remicade, lining up to get it on the U.S. market when J&J's treatment loses patent protection in 2018. Leading the charge in the U.S. is Novartis, expected to win approval this month for a biosimilar of Amgen's Neupogen, which boosts white blood cell production and is often used in tandem with chemotherapy.
On its heels is Apotex, whose take on Neupogen is currently under FDA review, while Novartis' Sandoz, a global leader, is working up copies of Humira, Enbrel, Rituxan and Procrit. In diabetes, Eli Lilly ($LLY) and Boehringer Ingelheim are pressing forward with a Lantus biosimilar of their own but have been hamstrung by an ongoing legal challenge.
- listen to the presentation