Amgen’s Wezlana (ustekinumab-auub) has been approved by the US Food and Drug Administration (FDA) to treat multiple inflammatory diseases.
Wezlana is now approved as a biosimilar to and interchangeable with Janssen Pharmaceuticals’ Stelara (ustekinumab).
Wezlana will be used to treat adults and paediatric patients aged six years or older with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.
Additionally, the interchangeable biosimilar can be used as a treatment option for adults with moderately to severely active Crohn’s disease and active ulcerative colitis.
A biosimilar, according to the FDA, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.
“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” said Nikolay Nikolov, director, office of immunology and inflammation, in the FDA’s Center for Drug Evaluation and Research (CDER).
The approval was based on a comprehensive review of scientific evidence which demonstrated that Wezlana is highly similar to Stelara, with no clinically meaningful differences between the products in terms of safety, purity and effectiveness.
Wezlana and Stelara were also confirmed to have similar comparative human pharmacokinetic data, clinical immunogenicity data and other clinical safety and effectiveness data.
Additionally, the safety profile of the interchangeable biosimilar was similar to that of Stelara.
Inflammatory diseases occur when the immune system causes inflammation by mistakenly attacking the body’s own cells or tissues.
“This approval can empower patients by helping to increase access to safe, effective and high-quality medications at [a] potentially lower cost,” said Sarah Yim, director, office of therapeutic biologics and biosimilars, FDA’s CDER.
Previously, the IL-12 and IL-23 inhibitor Stelara received FDA approval in 2009 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
It later received additional approvals for several inflammatory diseases, including Crohn’s disease and ulcerative colitis.
Most recently, Janssen’s Stelara received FDA approval for the treatment of paediatric patients aged six years and older with active psoriatic arthritis (PsA) in August.