The European Commission (EC) has approved Celltrion’s Omlyclo (CT-P39), an omalizumab biosimilar referencing Novartis and Genentech’s Xolair, for a range of immunological conditions.
Omlyclo, which has been authorised for use in patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps, is now the first omalizumab biosimilar approved in Europe.
A biosimilar, according to the European Medicines Agency (EMA), is a biological medicine that is highly similar to one already approved in the EU. 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.
Hyoung-Ki Kim, vice chairman at Celltrion, said: “Immunological conditions such as asthma can have a significant impact on the day-to-day lives of patients without appropriate treatment and care.
“This is why we are pleased to receive the first EC approval for an omalizumab biosimilar in Europe, an important step towards improving patient access to treatment.”
The EC’s decision follows a recent recommendation from the EMA’s human medicines committee and is supported by clinical evidence including positive results from a global phase 3 trial, which compared Omlyclo against Xolair in patients with the skin condition CSU for up to 40 weeks.
“For more than two decades, omalizumab… has revolutionised the management of chronic immune-mediated inflammatory diseases,” said Marcus Maurer, of the Fraunhofer Translational Medicine and Pharmacology ITMP and the Institute of Allergology.
“The development of a biosimilar of omalizumab is a welcome solution to help alleviate some challenges with treatment access,” Maurer added.
Omlyclo is Celltrion’s sixth biosimilar and is currently under review by the US Food and Drug Administration.
The EU approval comes shortly after Xolair was approved by the FDA for the reduction of allergic reactions, including anaphylaxis, in children and adults with IgE-mediated food allergies.
The US regulator’s February decision was based on positive results from the National Institutes of Health-sponsored phase 3 OUtMATCH study, which evaluated the drug in patients aged one to 55 years who are allergic to peanuts and at least two other common foods.