New data shows Sandoz’s Enbrel biosimilar has equivalent efficacy profile

pharmafile | July 7, 2016 | News story | Research and Development, Sales and Marketing |  Amgen, EMA, Enbrel, FDA, Novartis, Sandoz, biosimilars 

Sandoz has announced new data confirming the equivalent safety and efficacy profile of their biosimilar version of Enbrel (etanercept) in patients with moderate-to-severe chronic plaque-type psoriasis.

The Novartis division recently presented data at the European Congress of Rheumatology (EULAR 2016) demonstrating the pharmacokinetic bioequivalence of this, and other, biosimilars. The company has already submitted their biosimilar version of Enbrel to the EMA and FDA for approval.

In the EGALITY trial, presented at the 5^th Congress of the Psoriasis International Network in Paris, the biosimilar met the primary endpoint of achieving equivalence in Psoriasis Area and Severity Index (PASI) 75 response rates at week 12 was met.

Malte Peters, head of global clinical development in biopharmaceuticals at Sandoz, says: “The EGALITY data, showing our biosimilar etanercept to be bioequivalent to the originator product, is part of the comprehensive data package submitted to the EMA and the FDA. If our biosimilar etanercept is approved for the same indications as the originator product, more patients with chronic inflammatory conditions like rheumatoid arthritis and psoriasis will have access to life-changing biologic treatment options.”

The makers of the originator product, Amgen, have been pursuing methods to protect the sales of their blockbuster drug and prevent Sandoz’s biosimilar getting to market. This included filing a suit in a US court to prevent sales of the biosimilar if the FDA were to approve it.

Sandoz is seeking approval in all of Enbrel’s current indications in its regulatory submission. Decisions from the regulators are expected later this year.

Sean Murray