Amgen, Sandoz trial over Enbrel patents likely delayed—and a biosimilar could be, too

Amgen and Sandoz are locked in an Enbrel patent trial with blockbuster sales implications. (Pixabay)

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.  


Veeva 2020 Unified Clinical Operations Survey

We believe you have the knowledge and expertise to make this year's Veeva 2020 Clinical Operations Report even more robust and insightful than the last. Please take a moment to share your opinion in this 10-minute survey. All qualified respondents will be entered to win a $500 Amazon gift card.

RELATED: Sandoz head: Enbrel biosimilar Erelzi won't launch before 2018, delayed by legal battle 

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.

RELATED: Samsung's Enbrel biosim grabs share lickety-split, but production may cap growth 

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.

Suggested Articles

Amid Amgen's pricing war with Sanofi and Regeneron's Praluent, PCSK9 cholesterol fighter Repatha has shown a clinical benefit for HIV patients.

A month after the FDA approved it, Esperion's Nexletol showed it can lower cholesterol regardless of statin and ezitimibe treatment.

AstraZeneca's Farxiga can help prevent worsening or death in heart failure patients regardless of other therapies received, according to new data.