Celltrion said on Sept. 3 that it will start producing Remsima drug substance after signing a Contract Manufacturing Organization (CMO) with Lonza, a consignment production company.
Celltrion will form a consignment production partnership for pharmaceuticals, given that Lonza, a Basel-based comprehensive CDMO company in Switzerland, is a global CMO company armed with world-level CGMP production facilities.
In June last year, the two companies signed a contract that calls for the consignment production of Remsima drug substance in Europe and North America through its plant in Singapore.
The two companies applied for permission from the European Medicines Agency (EMA) for products produced at the Singapore plant after a validation period to verify the quality of their production facilities from the first quarter of this year.
Following Europe, the two companies plan to work together for approval of the Food and Drugs Administration (FDA) of the U.S.
Remsima, produced at Lonza's Singapore plant, will be supplied to Europe and North America after permission from global regulators such as EMA and FDA.
"As demands for biosimilars have soared globally, we have formed a cooperative relationship with Lonza to provide smooth supplies in a timely manner," a Celltrion official said. "We are also working closely together to respond to growing global demand, including the launch of new products that follow Remsima in the future."