![\"null](\"https:\/\/www.europesays.com\/korea\/wp-content\/uploads\/2026\/07\/1783663752_239_news-g.v1.20260705.8f6d6239b7ea40aa8a3718c214f0388e_P1.jpg\"\/ "\\"Samsung")
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Samsung Biologics (207940.KS) will produce the drug substance (DS) for AstraZeneca’s Saphnelo subcutaneous (SC) injection, a treatment for systemic lupus erythematosus (SLE). This marks the second known SC-formulation drug contract manufacturing (CMO) order for Samsung Biologics, following Johnson & Johnson’s Rybrevant SC. As global big pharma companies increasingly convert key biologics facing patent expiration into SC formulations, Samsung Biologics’ SC-formulation DS orders are also expected to expand.<\/p>\n
According to industry sources on Thursday, Samsung Biologics will handle the drug substance production for Saphnelo SC. Saphnelo is an SLE autoimmune disease drug approved in 2021. The SC formulation received U.S. Food and Drug Administration (FDA) approval in April this year and will begin full-scale sales in the second half. However, the specific production volume and supply countries for the order Samsung Biologics won were not disclosed. A Samsung Biologics official said, “We cannot disclose order contracts with clients due to a non-disclosure agreement (NDA).”<\/p>\n
Samsung Biologics’ latest order is drawing attention because it was signed as big pharma companies have been carrying out SC-formulation conversions of their key drugs one after another. By converting to SC formulations, big pharma companies can secure new formulation patents to extend product patent life and delay biosimilar competition. Moreover, SC formulations can reduce the number of hospital visits compared with intravenous (IV) formulations, making them highly preferred by both patients and medical staff.<\/p>\n
In fact, in the case of Johnson & Johnson’s Darzalex (a targeted anticancer drug for multiple myeloma), the company successfully defended its market position by converting more than 80% of existing IV patients to the SC formulation after its SC launch. Roche also launched Phesgo, an SC formulation combining Herceptin and Perjeta, while Bristol Myers Squibb (BMS) launched Opdivo SC and Merck (MSD) launched Keytruda SC, strengthening their SC strategies. Market research firm Mordor Intelligence forecasts that the global SC biologics market will grow from $286.3 billion (438.039 trillion won) this year to $498.9 billion (763.317 trillion won) by 2031.<\/p>\n
Saphnelo SC is also a product AstraZeneca introduced to expand its market share in the SLE market. SLE is a rare autoimmune disease in which inflammation occurs throughout the body due to immune system abnormalities. Because it requires long-term, consistent medication, SC formulations that allow self-administration have significant competitive advantages.<\/p>\n
Currently, GSK’s Benlysta has established itself as a leading treatment in the market, led by its SC formulation since 2017. Benlysta’s global sales last year totaled 1.773 billion pounds (3.6221 trillion won), far exceeding Saphnelo’s sales of $686 million (1.0495 trillion won).<\/p>\n
This shift toward SC formulations is seen as a new growth opportunity for Samsung Biologics as well. In particular, AstraZeneca, an existing client, is developing Enhertu SC and Imfinzi SC using the hyaluronidase technology of Alteogen, a domestic SC platform company. In addition, AstraZeneca is pursuing SC-formulation development of three anticancer drugs through its subsidiary MedImmune, raising the possibility of additional production orders in the future.<\/p>\n
Samsung Biologics is also accelerating the establishment of production infrastructure in preparation for SC market expansion. In 2024, the company launched S-HiCon, a high-concentration formulation contract development (CDO) platform that can be used for SC formulations. Along with this, the company plans to build fully automated prefilled syringe (PFS) and auto-injector (AI) production facilities by 2027. Once these facilities are completed, the company will be able to provide integrated services extending beyond drug substance production to SC-formulation drug product (DP) production.<\/p>\n
A bio industry official said, “If a full-cycle production system spanning from contract development to drug products is established, Samsung Biologics’ competitiveness will also increase amid the SC-conversion trend among global big pharma companies.” According to the Korea Biotechnology Industry Organization, Samsung Biologics’ biopharmaceutical CMO scale in 2024 was $1.6 billion, ranking behind Switzerland’s Lonza ($4.2 billion) and China’s WuXi Biologics ($1.8 billion). By market share, it recorded 7-9%, following Lonza (19-21%) and WuXi Biologics (7-10%).<\/p>\n","protected":false},"excerpt":{"rendered":"Samsung Biologics (207940.KS) will produce the drug substance (DS) for AstraZeneca’s Saphnelo subcutaneous (SC) injection, a treatment for…\n","protected":false},"author":2,"featured_media":81210,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[19],"tags":[34919,40952,40951,40954,127,505,40949,40953,40950],"class_list":["post-81209","post","type-post","status-publish","format-standard","has-post-thumbnail","category-samsung-biologics","tag-astrazeneca","tag-biologics-manufacturing","tag-drug-substance-cmo","tag-s-hicon-platform","tag-samsung","tag-samsung-biologics","tag-saphnelo-sc","tag-sc-biologics-market","tag-subcutaneous-formulation"],"_links":{"self":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts\/81209","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/comments?post=81209"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/posts\/81209\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/media\/81210"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/media?parent=81209"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/categories?post=81209"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/korea\/wp-json\/wp\/v2\/tags?post=81209"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}