Samsung Bioepis to sell cancer biosimilar in EU

Samsung Bioepis became the first company to receive regulatory approval to launch sales in Europe of its biosimilar for Herceptin - the world’s 8th bestselling biomedicine - according to the company on Monday.

The approved biosimilar of the cancer treatment Herceptin is Ontruzant. Samsung’s biopharmaceutical arm received marketing authorization Friday from the European Commission, which applies to all 28 countries in the European Union as well as Norway, Iceland and Liechtenstein.

Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to an original biomedicine. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but cost less.

The exact timeline of when sales will start per country is to be decided according to discussions with Merck Sharp and Dohme (MSD), Samsung’s sales partner for Ontruzant in Europe.

Developed by Swiss pharmaceutical company Roche, Herceptin contains trastuzumab - an antibody mainly used to treat early and metastatic breast cancer and metastatic gastric cancer. Last year alone, the product generated sales of approximately 7.8 trillion won ($7.11 billion) and is the eighth best-selling biomedicine worldwide.

Roche’s patent for the product in the European market expired in 2014, which prompted a handful of global pharmaceuticals to develop biosimilars. Other competitors waiting for approval to sell Herceptin biosimilars in Europe are Korea’s Celltrion, which submitted papers in October 2016, and the U.S.’s Amgen and Allergan, which submitted papers in March this year.

Samsung Bioepis said in Monday’s statement that the approval will help Ontruzant to establish a firm ground in the European market as a “first mover.”

The company embarked on procedures to acquire the European Commission’s approval last August. In September, Ontruzant received a “positive opinion” from the Committee for Medicinal Products for Human Use, which is a committee under the EU that evaluates medicinal products before they receive final approval.

For the verification process, biosimilars have to prove that they are clinically similar to the biomedicine and be tested for safety.

For Samsung, Ontruzant is also significant in that it is the first biosimilar for cancer treatment among the company’s products that can be sold in Europe.

The biopharmaceutical company now has biosimilars for four among the top 10 best-selling biomedicines in Europe - a record unmet by any of its global competitors.

BY SONG KYOUNG-SON [song.kyoungson@joongang.co.kr]