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Merck launches trastuzumab biosimilar in the US Posted 24/04/2020

US pharma giant Merck (known as MSD outside the US and Canada) and Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced in on 15 April 2020 that they had launched their trastuzumab biosimilar, Ontruzant, in the US.

Ontruzant is available in both 150 mg single-dose vials and 420 mg multiple-dose vials. The drug Ontruzant will be introduced in the US at a list price (wholesaler acquisition cost) of approximately US$1,325 for the 150 mg single-dose vial and US$3,709 for the 420 mg multiple-dose vial (prices are rounded), representing a 15% discount to the current list price of the originator biological, Roche’s Herceptin.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Merck and Samsung Bioepis initially agreed to collaborate on biosimilars back in 2013, when they made a deal to manufacture and commercialize MK‑1293, a biosimilar insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes [1].

Under the terms of the agreement for trastuzumab, Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration. While Merck will be responsible for all commercialization activities for products approved in its partnered territories, including the US.

Ontruzant was approved by the US Food and Drug Administration (FDA) in January 2019 [2]. The FDA’s approval was based on the review of a comprehensive data package, which included extensive structural and functional analytical data, non-clinical and clinical pharmacokinetic data, and a comparative clinical study demonstrating that Ontruzant is highly similar to its reference product, Herceptin, in terms of the safety, purity and potency of the product.

Samsung Bioepis also received European approval for its trastuzumab biosimilar, Ontruzant, in November 2017 [3], and announced on 24 March 2020 that it had received FDA approval for the 420 mg multi-dose vial version of Ontruzant (trastuzumab-dttb) in the US. This biosimilar will also be marketed in the US by Merck, until the spin-off company for biosimilars, which Merck announced in February 2020 [4], is up and running. This is intended to take place in the first half of 2021, at which time Ontruzant will become a product of the new company.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Merck and Samsung Bioepis collaborate on biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Biosimilars/News/Merck-and-Samsung-Bioepis-collaborate-on-biosimilar-insulin
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-trastuzumab-biosimilar-Ontruzant
3. GaBI Online - Generics and Biosimilars Initiative. EC approval for trastuzumab biosimilar Ontruzant [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-trastuzumab-biosimilar-Ontruzant
4. GaBI Online - Generics and Biosimilars Initiative. Merck to create spin off for women’s health and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 24]. Available from: www.gabionline.net/Pharma-News/Merck-to-create-spin-off-for-women-s-health-and-biosimilars

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Source: Merck, Samsung Bioepis

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