Ontruzant, the biosimilar version of Herceptin (trastuzumab ) originally developed by Korean firm Samsung Bioepis, has launched for patients in the UK, becoming the first biologic copycat version of Roche’s blockbuster to be available in the region.

MSD, better known as Merck across the Atlantic, is handling marketing as part of a global biosimilars development and commercialisation agreement with Samsung Bioepis.

The decision was based on data which indicated that Ontruzant was non-inferior to its reference product in safety and efficacy and highly similar in structure, biological activity and immunogenicity profile. In the treatment of early breast cancer, Ontruzant recorded a complete response rate of 51.7% compared to Herceptin’s 42%, and an overall response rate of 96.3% compared to 91.2%.

The approval at the end of last year marked the fourth that Samsung Bioepis had secured in Europe for biosimilar medicines, and the second biologic copy of Herceptin approved in the region following the authorisation of Celltrion’s Herzuma.

"This is good news for so many cancer patients and the NHS. The launch of biosimilar trastuzumab provides a high-quality treatment alternative for patients, while offering significant potential savings for the NHS," commented Dr Mark Verrill, Head of the Department of Medical Oncology at the Newcastle upon Tyne Hospitals NHS Foundation Trust, and the Deputy Lead Clinician for Breast Cancer in the North of England Cancer Network. "The biggest category of medicines in oncology is monoclonal antibodies and the introduction of biosimilars such as trastuzumab could provide a substantial cost saving."

Earlier in the week, Daewoon Pharmaceutical launched the biosimilar in Samsung Bioepis’ home country of Korea, following its approval in November last year.

Herceptin was the fourth-highest-earning drug in 2017, generating revenues of $7.4 billion, and the news of a new biologic competitor will almost certainly mean that Roche can expect its share of the market to be impacted, though the company’s Chief Executive Daniel O’Day reassured investors that the firm has the resilience to power through this competition.

Louise Houson, UK Managing Director at MSD, also commented: "As a company committed to inventing new treatment options for both common and neglected types of cancer, MSD is also pleased to be offering the NHS a biosimilar medicine in an established area of care. Biosimilar trastuzumab marks a significant milestone for both MSD and the oncology community, providing the UK’s first biosimilar trastuzumab, based on our collaboration with Samsung Bioepis."

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