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MSD launches EU’s first biosimilar Herceptin in UK

Ontruzant is set to be strong competition for Roche’s blockbuster


The first biosimilar version of Roche’s blockbuster breast cancer drug Herceptin has been launched in the UK by MSD under the Ontruzant brand name.

The new biosimilar will be sold in Europe by MSD - known as Merck & Co in North America - but was originally developed by South Korean biotech Samsung Bioepis. Merck licensed certain geographic rights to the biosimilar, as well as versions of other top-selling biologic drugs in Samsung Bioepis’ pipeline, in 2013.

Herceptin (trastuzumab) was Roche’s second-biggest product last year, bringing in more than CHF 7bn ($7.4bn), and the onset of biosimilar competition in Europe is expected to start to put pressure on some CHF 2.1bn in sales for the brand in the region, although UK pricing details were not available at the time of writing.

Ontruzant was approved by the EMA last November for the full range of registered indications for Herceptin, including early breast cancer, metastatic breast cancer and metastatic gastric cancer. Clinical trials of the drug showed it to be comparable to Herceptin in terms of structure, biological activity and efficacy, safety and immunogenicity profile, said MSD in a statement.

In the treatment of early breast cancer, for example 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%, according to the pharma company.

Ontruzant isn’t the only Herceptin biosimilar approved for marketing in Europe. Another South Korean firm - Celltrion - secured EMA backing for its Herzuma version of the drug last month. Both of these drugs are however copies of the older intravenous form of Herceptin, which is now used in only around half of Herceptin patients since Roche introduced a new subcutaneous formulation of the drug - which is easier and quicker to administer.

Roche has particularly high exposure to biosimilar erosion in the coming years in its first-generation antibody products - with Avastin (bevacizumab) and MabThera (rituximab) also under threat along with Herceptin - but has insisted it can ride out the storm with new products such as multiple sclerosis therapy Ocrevus (ocrelizumab) and cancer drugs Perjeta (pertuzumab), Tecentriq (atezolizumab) and Alecensa (alectinib).

Mark Verrill, head of the Department of Medical Oncology at the Newcastle upon Tyne Hospitals NHS Foundation Trust, welcomed the launch, saying it “provides a high-quality treatment alternative for patients, while offering significant potential savings for the NHS”.

“The biggest category of medicines in oncology is monoclonal antibodies and the introduction of biosimilars such as trastuzumab could provide a substantial cost saving,” he added.

Ontruzant was the fourth biosimilar developed by the Korean company to receive marketing authorisation in the EU, after Benepali (etanercept), Flixabi (infliximab), and Imraldi (adalimumab).

Article by
Phil Taylor

9th March 2018

From: Regulatory



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