Noticia de Contratación

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). 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.

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.

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).