HONG KONG – Global pharmaceutical company Mundipharma Pte Ltd. is gaining exclusive commercialization rights in Taiwan and Hong Kong to four biosimilar candidates from South Korean biopharma Samsung Bioepis Co. Ltd. targeting immunology and oncology.
Mundipharma Singapore, which covers a global network across Asia Pacific, Latin America, the Middle East and Africa, is in charge of the partnership. Bioepis, based in Suwon, will remain the marketing authorization holder, responsible for clinical R&D, regulatory registration and manufacture of the biosimilars.
“The partnership is valid for a period of 10 years,” Yoon Kim, manager of global communications at Samsung Bioepis, told BioWorld Asia, though specific financial details were not disclosed.
“We are unable to provide the timeline for the launches of each product; however, we look forward to working with Mundipharma to realize our shared commitment to improve the quality of health care for patients across Taiwan and Hong Kong,” Kim added.
Mundipharma CEO Raman Singh said the partnership will help to address immunology and oncology patient needs in two important territories in Asia.
Three of the candidates, SB-5, SB-4 and SB-3, have been commercialized in the global markets, while SB-8 awaits FDA marketing approval. SB-5, a Humira biosimilar, covers various indications, including rheumatoid arthritis (RA), juvenile idiopathic arthritis and enthesitis-related arthritis, axial spondyloarthritis (AS), psoriatic arthritis (PsA), psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa and Crohn's disease. It has been launched in Europe, the U.S. and Korea. The product has rapidly increased its share in the European market, under name of Imraldi, with cumulative sales of $149 million from October 2018 to September 2019. Imraldi had sales of $49.3 million during the third quarter of 2019, according to Bioepis’ European marketing partner, Biogen Inc. The drug was the leading adalimumab biosimilar, especially in Germany in 2019.
SB-4, an Enbrel biosimilar, is indicated for diseases including RA, AS, PsA and plaque psoriasis. It has been launched in Europe, the U.S., Australia, Canada and Korea. Under the name of Benepali, the biosimilar posted $115.9 million in sales in 25 countries in Europe during the third quarter of last year. It is the most prescribed etanercept in France, Germany, Italy, Spain and the U.K.
SB-3, a Herceptin biosimilar, covers HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. The biosimilar is available in Europe, the U.S., Australia and Korea.
SB-3 aims to enter the Chinese market as well. Its phase III trial application was approved by China’s National Medical Products Administration (NMPA) in December. The study is expected to kick off this quarter. Affamed Therapeutics Co. Ltd., a Shanghai-based biopharmaceutical company founded by private equity firm C-Bridge Capital Partners LLC, is collaborating with Bioepis on clinical R&D, regulatory activities, and the commercialization of biosimilar products in China.
A BLA for SB-8 was accepted for review by the FDA in November. The Avastin biosimilar has indications for metastatic colorectal cancer and non-small-cell lung cancer (NSCLC). If approved by the FDA, it will be marketed in the U.S. by Merck & Co. Inc., which has also been Bioepis’ partner for its biosimilar infliximab, Renflexis.
In order to secure its future biosimilar market, Bioepis has newly partnered with Biogen for the commercialization of two biosimilar candidates, SB-11¸ referencing ranibizumab, and SB-15, referencing aflibercept, in the U.S., Canada, Europe, Japan and Australia. SB-11 is undergoing phase III testing, while SB-15 is in preclinical development.
Currently, Mundipharma International Ltd., headquartered in Cambridge, U.K., is actively seeking to expand its biosimilar business. It has marketed four biosimilars in Europe: Remsima (infliximab), Truxima (rituximab), Herzuma (trastuzumab) and Pelmeg (pegfilgrastim). Pelmeg was originally developed by Hungarian pharmaceutical firm Egis Pharmaceuticals plc, and the other three biosimilar products were developed by Celltrion Inc., a leading biosimilar producer in Korea.
In July 2019, the U.K. company also partnered with Singapore-based biopharma Prestige Biopharma Pte Ltd. for an exclusive license and supply of Tuznue, a trastuzumab biosimilar. The terms of agreement state that the Mundipharma network will distribute, market and sell Tuznue in part of Europe following marketing authorization, including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria.