創新生物藥,生物相似藥與生物改良藥:台灣生物製藥產業之發展

Innovative Biologics, Biosimilars and Biobetters: Development of Biopharma Industry in Taiwan

王仁宏(Ren-Hong Wang)

指導教授 ： 朱博湧

國立交通大學/管理學院/管理學院高階主管管理碩士學程/碩士(2018年)

摘要

生物製藥業近廿年來的快速發展，使其成為傳統製藥以外的一個舉足輕重的產業。 公元 2016 年的全球生物製藥營收已超過美金 1600 億美元。然而，這些成本昂 貴的生物製藥由於即將到期的專利保護，促使了生物相似藥(biosimiliars)的應蘊 而生，該新興產業熱潮也迅速席捲全球；希望生物相似藥的出現能為病人帶來所 能普遍接受的價格與較好的醫療服務。然而，鑑於生物製藥工藝的複雜性，生物 相似藥品價格的大幅調降似乎未如預期；主要乃因臨床試驗所需的費用和時間與 原廠藥相差不大。另一方面，歐美大藥廠為了因應其產品的專利到期後，市場上 出現生物相似藥競爭的局面；除了致力於開發全新功能的藥物外，其憑藉著對自 家原產品的藥理與製造工藝所已掌握的優勢，順勢開發第二代藥品-生物改良藥 (biobetters)，以延續市場獨佔的優勢。因此，生物相似藥廠要找適合的價值定位 是相當困難。 公元 2000 年初台灣生物製藥產業在政府積極扶植下，如雨後春 筍般地萌發與茁壯。這些新興生物製藥公司依據其各自的專長，分別將經營策略 著重於創新生物藥，生物相似藥或者生物改良藥的開發；但相較於近鄰韓國這幾 年所培育出的 Celltrion 與 Samsung BioLogics 等生技大製藥廠已打響其企業特 色與國際品牌，國內生物製藥產業逾十五年的努力，似乎無法交出具體成果能與 之相提並論。面對著台灣島內極有限的醫療市場、特殊的地理位置、以及巨大而 快速變遷的中國大陸市場，未來台灣生物製藥產業的定位與發展策略之選擇將是 該產業所應嚴謹面對的議題。

關鍵字

生物藥劑 ； 創新生物藥 ； 生物相似藥 ； 生物改良藥

並列摘要

Biologics have been gaining significant attraction in the pharmaceutical industry in last two decades. However the high cost of biologics has become an important issue in the battle concerning ever-increasing healthcare costs. In 2016 the global sales of biologics were over USD 160 billion. The blockbuster biologics that face recent loss in exclusivity or patent expiration create opportunities for the development of copy version of these medicinal products with similar biological activities (biosimilars). Wave of biosimilars is coming to the world overwhelmingly. There have been concerns over the degree of biosimilarity of these copy biologics due to the complex structures in addition to the hope that their introduction may reduce the cost of such expensive therapeutics. On the other hand, big biopharmas are dedicating to the development of second-generation medicines (biobetters) in order to reduce the impact of potential biosimilars on their market shares. Fierce competition of biosimilar markets is under our expectations. The biotech startups have been blooming under the Taiwanese government’s supports since early 2000s. Their business strategies are diverse between innovative, biosimilars and biobetters based on their expertise and platforms. In contrast to Celltrion and Samsung BioLogics supported by South Korean government, we lack a lead biotech firm in Taiwan that can compete with them. Given the limit of market size in Taiwan, unique geographical location and huge yet quick changing market in China, how to identify the market niche and well define business strategies are important topics to the biopharma industry in Taiwan today.

並列關鍵字

biologics ； biobetters ； biosimilars

參考文獻

1. 商業周刊 第 729 期, 2001/11/08.

2. 今周刊 第 341 期, p.88, 2003/07/03.

3. New leadership, funding set to boost Taiwan's biopharma industry, BIOPHARMA INDUSTRY IN TAIWAN, March 30, 2016.

4. Niosi J. 2016. Imitation and innovation new biologics, biosimilars and biobetters. Technology Analysis & Strategic Management.

5. V. Sandeep, J. Parveen, Chauhan P. Biobetter: the better biologics and their regulatory overview. International J. of Drug Regulatory Affairs; 2016, 4(1), 13-20.