Samsung Bioepis contracts Catalent to help commercialize Benepali

By Gareth Macdonald contact

- Last updated on GMT


Related tags: Psoriatic arthritis, Rheumatoid arthritis

Samsung Bioepis has contracted Catalent to provide fill finish services for its Enbrel (etanercept) biosimilar, 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 (CMO) 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. (known as MSD outside North America) will hold marketing authority in other markets, excluding US where Amgen has exclusivity until 2028.


Kimberlee 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 (PFS) filling capacity but we have added additional staff to handle the secondary packaging activities​."

She added that: "Catalent’s Brussels facility currently has PFS capacity of more than 200 million syringes per year, plus extensive refrigerated and freezer capacity to meet the needs of biologics/cold chain clients.

"Catalent is expanding its secondary packaging capabilities by installing automated autoinjector assembly, which is often required for self-administered products, by the middle of 2017, and will continue to expand its sterile manufacturing and packaging capacity to meet the needs of our customers​."

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