- Novartis' generics unit Sandoz on Tuesday secured market authorization from the European Commission (EC) for its biosimilar version of the blockbuster anti-inflammatory disease drug Enbrel (etanercept), adding a fifth copycat biologic to its biosimilar portfolio in the EU.
- The green light for Erelzi, as the biosimilar will be sold in EU member states, comes a week after the EC approved Sandoz's biosimilar copy of Roche's Rituxan (rituximab) drug.
- Amgen markets Enbrel in the U.S., where Sandoz has already won approval for Erelzi from the Food and Drug Administration. In Europe and elsewhere, Enbrel is sold by Pfizer, earning $1.85 billion in revenues from the developed Europe region last year.
Novartis has made biosimilars a priority and, so far, Sandoz is largely executing on the Swiss pharma's ambition to file 11 biosimilars for approval in the U.S. and Europe by the end of this year. That aggressive push into biosimilars is expected to result in five market launches through 2020.
Sandoz currently markets Omnitrope (somatropin) and Binocrit (epoetin alfa) in Europe, and Zarxio (filgrastim-sndz) in the U.S. Despite winning approval for Erelzi in the U.S., the generics unit hasn't launched the drug on the market yet due to ongoing patent litigation.
Erelzi's approval in Europe was supported by a pharmacokinetic study that demonstrated bioequivalence to Enbrel — without any clinical relevant differences in safety, tolerability or immunogenicity. A Phase 3 study called EGALITY also showed that the two medicines achieved similar efficacy and safety outcomes and immunogenicity in psoriasis patients.
That trial included three treatment switches between Enbrel and Erelzi, finding no significant differences between the two drugs in mean Psoriasis Area and Severity Index (PASI) responses over 52 weeks.
An increasing pace of biosimilar approvals could threaten market share and sales for the handful of top-selling immunology drugs like Enbrel and cancer drugs like Rituxan.
Last week, the European Medicines Agency recommended approval for Samsung Bioepis' biosimilar of AbbVie's inflammatory drug Humira (adalimumab). Sandoz also plans to submit applications for an approval of its own Humira biosimilar.