Samsung Bioepis contracts Catalent to help commercialize Benepali

Samsung Bioepis contracts Catalent to help commercialize Benepali

The deal – financial terms of which were not disclosed – will see Catalent process the drug – also known by the Samsung code name SB4 – at its pre-filled syringe facility in Brussels, Belgium. In addition to filling and finishing Benepali, the US contract manufacturing organisation will package the product. The facility has annual syringe filling capacity of more than 200 million units. A spokesman confirmed that products filled and finished by Catalent will be sold in multiple markets around the world.Benepali was approved by the European Commission in January .The drug substance – a biosimilar of Amgen’s Enbrel that is indicated for adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis – will be made by Samsung’s partner Biogen at its plant in Hillerød, Denmark.Biogen will also be responsible for selling Benepali in Europe and Japan. Merck Co. will hold marketing authority in other markets, excluding US where Amgen has exclusivity until 2028.
CapacityKimberlee Steele, Director, Catalent Drug Delivery Solutions, told us the firm has hired more staff in light of the contract. Catalent is utilizing existing pre-filled syringe filling capacity but we have added additional staff to h…

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