Merck's ($MRK) copies of the blockbuster anti-inflammatory treatments Enbrel and Remicade met their goals in Phase III, burnishing the pharma giant's plans to elbow its way into the long queue of companies readying cheaper versions of some of the world's best-selling medicines.
SB4, the Enbrel knockoff, proved itself equivalent to Amgen's ($AMGN) cash cow in a 596-patient study, Merck said, reducing symptoms of rheumatoid arthritis on pace with its reference product. And SB2, Merck's take on Remicade, stacked up against Johnson & Johnson's ($JNJ) blockbuster injection in a 584-patient study.
The results, presented at the European League Against Rheumatism meeting in Rome, will form the backbone of regulatory submissions Merck plans to file this year, the company said.
Merck, playing catch-up in the biosimilars race after a string of setbacks, is working with Samsung Bioepis, a joint venture between the South Korean giant and Biogen ($BIIB). Under a 2013 agreement between the two, Merck gets the marketing rights in certain nations to a slew of candidates while its partner handles R&D. Beyond Enbrel and Remicade, the two are at work on copies of AbbVie's ($ABBV) Humira, Sanofi's ($SNY) blockbuster insulin Lantus and Roche's ($RHHBY) cancer treatment Herceptin.
"Our collaboration with Samsung Bioepis to develop and commercialize multiple biosimilar candidates in our partnered markets is making significant progress, with 5 late-stage biosimilar candidates expected to be filed with regulatory authorities around the world within the next two years," Merck biosimilars chief Dora Bibila said in a statement.
Meanwhile, the long-expected arrival of copycat biologic blockbusters is rapidly becoming a reality, as Novartis ($NVS) won FDA approval for a version of Amgen's blockbuster Neupogen in March, a milestone expected to help knockoff biologics bring in more than $35 billion by 2020 as more and more treatments lose patent protection, analysts say.
But Merck will to need steer through a thicket of conflicting licensing deals and intellectual property issues on its way to cashing in on biosimilars. Due to existing agreements, the company would have to limit sales of its Humira and Remicade biosimilars 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.
- read the statement