A patent fight has already delayed Sandoz' biosimilar version of Amgen's anti-inflammatory blockbuster Enbrel. And now, it looks as if Sandoz will have to wait a little longer for a clear shot at the launch.
The drugmakers had a much-anticipated patent trial set for later this month, but court filings suggest the companies are preparing for a trial now set to start on June 20, according to a note from Evercore ISI analyst Umer Raffat. Any delay benefits Amgen, which can continue to reap blockbuster-level sales with its branded med, without threat of copycat competition.
Novartis' Sandoz won FDA approval for its biosim in August 2016, but hasn't been able to launch because of the patent dispute.
Aside from the Enbrel threat, Amgen is bracing for possible U.S. competition to several other meds this year. Sensipar, Neulasta and Epogen could each face new biosims or generics this year, endangering billions in annual revenues for the California-based big biotech.
Enbrel won its initial approval in 1998 and pulled in $5.4 billion last year, a 9% decline. In Europe, biosims are doing so well that Samsung has warned of supply problems for its version. Lower demand and lower net prices drove the worldwide decline for Enbrel sales, the company reported in its fourth-quarter earnings release.
Analysts expect a steady revenue slide for Enbrel out to 2025, according to consensus figures provided by Raffat. Wall Street predicts Enbrel will bring in $2.859 billion that year.