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2019 Ends and 2020 Begins with a Flurry of Biosimilar Activity in East Asian Markets

A white paper released in 2019 by The Biosimilars Forum and Medicines for Europe shows the United States and Europe accounting for more than a combined 80% of sales of biologic medicines, and more than a combined 90% of biosimilars.[1] This, of course, has led to a focus on these markets for the biopharmaceutical industry.  However, as many in the industry are already aware, biopharmaceutical markets in East Asia are rapidly developing and represent a massive potential for growth for biosimilars.

For example, China is the second largest pharmaceutical market in the world,[2] but the China National Medical Products Administration (NMPA) only approved its first biosimilar in February 2019, Shanghai Henlius Biotech’s 汉利康® (pronounced “Han-li-kang”), which references Genentech and Biogen’s Rituxan (rituximab).[3] A second biosimilar, Bio-Thera’s QLELTLI®, which references Abbvie’s Humira® (adalimumab), was not approved by the NMPA until November 2019.[4] Despite this seemingly late start, it has been reported that China has approved more than 200 clinical trials for biosimilars,[5] and this is reflected by an increasing pace of approvals and other activity starting in the later part of 2019.

Beyond China, this increasing pace is reflected elsewhere in East Asia as discussed below, with approvals and other activity in South Korea and Japan.

This activity should signal not only an opportunity for expansion within these growing markets, but also a potential growth in competition that those in the industry, whether creating originator molecules or biosimilars, should be monitoring closely.

Biosimilar Development Activity:

Beyond the events described above, several major deals have been announced regarding the planned expansion of biosimilar activity into East Asian markets.

For example, on November 6, 2019, Samsung Bioepis and Biogen announced a commercialization agreement for two of Samsung Bioepis’s biosimilar candidates referencing Genentech’s Lucentis (ranibizumab) and Regenron’s Eylea (aflibercept) into several markets, including Japan.[15] This agreement also included an option for Biogen to commercialize three of Samsung Bioepis’s existing biosimilar products, Benepali (etanercept), Flixabi (infliximab), and Imraldi (adalimumab) in China.

January 12, 2020, saw Samsung Bioepis enter another commercialization agreement, this time with Mundipharma, for four of Samsung Bioepis’s biosimilar candidates into Hong Kong and Taiwan.[16]

Finally, on January 21, 2020, Celltrion announced that it planned to build a $500 million factory in China to begin manufacturing its biologics to supply the Chinese market.[17] However, Celltrion had chosen Wuhan as the location for its new facilities, and given that the Chinese city is at the center of the recent  coronavirus outbreak, it has recently been reported that these plans may be on hold.[18]

[1] http://biosimilarsforum.org/PDF/BIosimilars_WhitePaper-final.pdf

[2] https://pharmaceuticalcommerce.com/business-and-finance/global-pharma-spending-will-hit-1-5-trillion-in-2023-says-iqvia/

[3] https://www.fosunpharma.com/en/news/news-details-3749.html

[4] https://www.bio-thera.com/EN/ShowNews.asp?id=60

[5] https://www.parexel.com/news-events-resources/blog/biosimilars-china

[6] http://www.koreabiomed.com/news/articleView.html?idxno=6738

[7] http://www.mochida.co.jp/english/news/docs/2019/191127_teriparatideBS.pdf

[8] https://www.businesswire.com/news/home/20191204005310/en/

[9] http://www.gabionline.net/Biosimilars/News/China-approves-bevacizumab-copy-biological-Ankada

[10] https://www.globenewswire.com/news-release/2019/12/10/1958295/0/en/AffaMed-Therapeutics-Receives-NMPA-Approval-to-Initiate-Phase-III-Clinical-Trial-in-China-with-Herceptin-Trastuzumab-Biosimilar-Candidate-AMT901.html

[11] https://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/007086.html

[12] https://www.businesswire.com/news/home/20191230005088/en/Clover-Biopharmaceuticals-Initiates-Phase-III-Study-Etanercept

[13] https://www.globenewswire.com/news-release/2020/01/06/1966350/0/en/Sorrento-Announces-Filing-for-Approval-of-Infliximab-Biobetter-Antibody-by-Its-Partner-Mabpharm-in-China.html

[14] https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=145&currentPage=1

[15] https://www.samsungbioepis.com/en/newsroom/newsroomView.do?idx=138&currentPage=1

[16] https://www.biospace.com/article/releases/mundipharma-enters-partnership-with-samsung-bioepis-to-expand-biosimilars-into-hong-kong-and-taiwan/

[17] https://pharmaintelligence.informa.com/resources/product-content/2020/01/27/10/58/celltrion-sets-out-strategy-for-china; https://asia.nikkei.com/Business/Companies/Celltrion-plans-500m-factory-in-Wuhan-to-tap-China-drug-market

[18] https://www.centerforbiosimilars.com/news/celltrions-wuhan-plans-on-hold-amid-coronavirus-outbreak