Following the FDA’s approval of Hulio (adalimumab-fkjp), a biosimilar of AbbVie’s Humira that was the highest grossing drug for eight years running with $19.2bn in 2019 global sales, Hulio will be made available in July 2023 for all of Humira’s approved indications that are not protected by orphan exclusivity. Hulio joins five other FDA-approved adalimumab biosimilars*, however, as these drugs are unable to enter the US market until 2023 at the earliest, there is still time for more to be approved and substantial competition within the adalimumab biosimilars space is likely to drive higher discounts at launch, says GlobalData, a leading data and analytics company.

Heather Leach, PhD, Director of Immunology at GlobalData, comments: “To date, US payers have been underwhelmed by the pricing of biosimilars, citing that biosimilar infliximab is a mere 15% discount by list price compared to Janssen’s Remicade (infliximab). However, significant competition and contracting within anti-TNFα branded agents bring the negotiated price of Remicade close to that of its biosimilar. Nonetheless, there is still hope that the situation for adalimumab biosimilars will be different.

“With only two infliximab biosimilars launched in the US, competition is low for these biosimilars. In addition to this, Remicade and its biosimilars have additional costs associated with its infusion. This is contrasted to adalimumab biosimilars, for which there are already six approvals that are three years out from launch.”

Humira’s prestigious position as the highest-selling drug for nearly a decade running has clearly drawn interest from biosimilar developers. With 2019 sales of the drug at nearly $15 in the US alone, the stakes are high, and it is no surprise that payers are yearning for biosimilars to provide some relief.

* Amgen’s Amjevita, Boehringer Ingelheim’s Cyltezo, Sandoz’s Hyrimoz, Samsung Bioepis’ Hadlima, and Pfizer’s Abrilada