Developed by Korean drugmaker Samsung Bioepis, the biosimilar was given a positive opinion in September by the European Medicines Agency (EMA) and approved by the European Commission (EC) in November to treat various breast and gastric cancers.
Ontruzant has now launched in the UK, marketed by MSD (known as Merck & Co. in North America) which has a commercialisation agreement in place with Samsung Bioepis.
“We hope Ontruzant will play an important role expanding patient access to trastuzumab for patients in the United Kingdom,” Samsung Bioepis spokesperson Mingi Hyun told this publication.
“Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry's strongest biosimilar pipelines, so that more patients throughout the UK will benefit from biosimilars.”
Herceptin is Roche’s second largest product based on 2017 revenues, pulling in over CHF 7bn ($7.4bn) globally. In Europe it is Roche’s largest product, pulling in CHF 2.1bn for the Swiss Biopharma, something MSD is looking to get a slice of.
Samsung Bioepis – a biosimilar joint venture set up between Samsung BioLogics and Biogen – has previously told this publication it uses contract manufacturers for the production of Ontruzant and its other biosimilar products, but Hyun was unable to comment further on the details.