Trastuzumab triple: FDA approves Merck and Samsung Bioepis biosimilar

The FDA has approved Ontruzant, the third version of Roche’s cancer drug Herceptin, and the second US biosimilar approval for Samsung Bioepis. The product will be marketed by Merck & Co.

Europe approved Ontruzant in November 2017 as a biosimilar to Roche’s Herceptin (trastuzumab), and 14 months on the US Food and Drug Administration (FDA) has given the oncology biologic the regulatory thumbs up.

Ontruzant becomes the seventeenth biosimilar to be approved in the US, and the first of 2019. For developer Samsung Bioepis – a joint venture formed between Samsung BioLogics and Biogen – the biosimilar is the second to gain US approval after the firm’s version of J&J’s Remicade (infliximab), Renflexis received approval in April 2017.

Image: iStock/Vepar5

Like Renflexis, Ontruzant will be marketed in the US by Merck & Co. (known as MSD outside North America). No further details regarding launch date were divulged by Samsung Bioepis when contacted by BioProcess Insider.

The firm was also unable to comment on the production of the biosimilar, though according to FDA labelling information, Ontruzant is a “product of Denmark.” Biogen, which owns just under 50% of Samsung Bioepis, has a large-scale manufacturing facility in Hillerød, Denmark.

The trouble with trastuzumab

Ontruzant becomes the third trastuzumab biosimilar to be approved in the US, following Mylan and Biocon’s Ogivri in December 2017, and Celltrion’s Herzuma in December 2018.

But unlike the other two trastuzumab biosimilars, Ontruzant received approval without any manufacturing probems.

Biocon’s plant in Bangalore, India received criticism from both European and US inspectors in 2017, delaying approval. Meanwhile Herzuma’s approval came on the second attempt for Celltrion after the firm received a complete response letter (CRL) in April 2018, citing an FDA warning letter​ highlighting “multiple poor aseptic practices” at Celltrion’s production site in Songdo, Incheon.

Pfizer is yet to have its Herceptin biosimilar candidate approved but hit trouble last April when it received a complete response letter (CRL) highlighting the need for additional technical information.