領導者之決策對於組織的影響甚大，不僅決定企業的獲利，更可能影響組織的存亡。在現今快速變遷的環境中，領導者經常面臨在時間壓力下需快速做出正確的決策，因此本研究著重於探討領導者才能對於領導者決策品質，以及團隊競爭力與績效之影響。具體而言，本研究從Sternberg所提出的WICS模式為出發點，探討「領導者智慧」、「領導者實用智力」、「領導者分析智力」及「領導者創新能力」對於「領導者決策品質」、「團隊競爭力與績效」之影響，並建構「領導者才能之競爭力模式」。至於領導者才能之競爭力模式，不僅可以做為後續相關研究之重要參考，亦可協助企業與領導者檢視其領導效能，進而做為改善競爭力與績效之重要依據。 本研究之問卷經嚴謹之程序編製，首先進行專家會議、信效度及因素分析之檢驗，之後再進行研究變項間之探討。研究樣本採立意取樣方式，以團隊為單位，每個團隊收集團隊領導者及其五位直屬部屬之調查問卷。本研究總計回收40位領導者與200位部屬之有效樣本，統計分析結果顯示，本研究所有量表皆具有良好之內部一致性信度（.754~.972）與效標關聯效度（.280~.820）。 此外，本研究根據結構方程模式驗證本研究之假設，綜合結果顯示：1. 領導者智慧、實用智力、分析智力及創新能力對於領導者決策品質具有顯著且正向之影響；2. 領導者決策品質對於團隊競爭力具有顯著且正向之影響；3. 團隊競爭力對於團隊績效具有顯著且正向之影響；4. 「領導者才能之競爭力模式」獲得實證支持。最後，研究者根據本研究結果，提出對未來學術研究與實務應用具體之建議。 / Leaders’ decisions have a great impact on organizations; they influence not only the revenue but also the survival of organizations. In this fast-changing environment, leaders always need to make fast and correct decisions under time pressure. Therefore, the focus of this study is the effect of leaders’ skills on the quality of leaders’ decisions so as to improve the competitiveness and performance of teams or organizations. The present study starts from WICS model which developed by Sternberg to examine the effect of leaders’ wisdom, practical intelligence, analytic intelligence, and creativity on the quality of leaders’ decisions, team competitiveness and performance, and to construct the competitiveness model of leaders’ skills. The development of competitiveness model of leaders’ skills could not only be used by following related studies, but also assist organizations and leaders to review leadership efficacy in order to improve the competitiveness and performance. The present study constructed the questionnaire through an expert committee, tests of reliability, validity, and factor analysis. The samples of team unit were collected using purposive sampling, and each unit included one leader and five immediate subordinates. A total of forty valid sample units which had forty leaders and two hundred immediate subordinates were collected. Through the statistical analysis, it shows the internal consistency reliability (.752-.972) and criterion-related validity (.280-.820) of all scales (leaders’ self-rating and subordinates’ other-rating) were excellent. Furthermore, according to the result of hypothesis testing and Structural Equation Modeling analysis, it shows: 1. Leaders’ wisdom, empirical intelligence, analytic intelligence, and creativity have a significant and positive influence on the quality of leaders’ decisions; 2. The quality of leaders’ decisions has a significant and positive influence on team competitiveness; 3. Team competitiveness has a significant and positive influence on team performance; 4. The constructed competitiveness model of leaders’ skills was supported. Finally, suggestions were proposed for further academic studies and practical application based on the result of the present study.

Many studies have explored service innovations regarding the use of information technologies, yet few have addressed the strategic leveraging in IT investment for sustaining competitiveness. The objective of this paper is to examine different strategies that firms have applied in leveraging advanced information technologies for service innovation in highly competitive market. The analysis of strategy is developed based on two dimensions: (1) IT capability, referring to a firm’s ability to deploy IT-based resources, combined with (2) the firm’s complementary resources including customer and supplier relationships, financial capital. We investigate the convenience-store industry and telecommunication industry in Taiwan, are observed to be in the intensive competitive market in terms of the reduced sales growth, intensively innovations undertaken. The case analysis reveals that there are four types of strategies firms apply in leveraging IT for competitiveness: predator, inventor, follower, and hedger. We also found the transition of strategies for IT-enabled service innovation with resource reconfigurated as market evolved. We further identify the resource reconfiguration mechanism occur in the achievement of their sourcing approaches. Generally, this research explains firms’ continuous strategic changes and resource reconfiguration to sustain the advantages of IT-enabled service innovation in competitive market. We suggest a strategy model that includes the issues of the strategy content, path of strategy transitions, resource reconfiguration mechanisms, and resource sourcing approaches. This model provides a guideline for firms to decide their strategies towards different IT-enabled service innovations with the strategic resource configuration changes.

台灣半導體產業發展所形成獨特的產業垂直分工與產業上、中、下游完整價值鏈的群聚效應，是締造今日台灣IC設計產業快速成長的主因，2004年創造年產值83億美元(新台幣2,608億元)，在全球330億美元的產值中占有率近25%，世界排名第二。人才、資金、技術及市場是IC設計產業成功發展的基本要素，而「行銷通路管理(Sales-Channel M.」、「價值鏈管理(Supply-Chain M.」、「智慧資本管理(Intellectual-Property M.」、以及「顧客導向管理(Customer- Driving M.」之S2IC核心能力，則是台灣IC設計業者經營的關鍵成功因素(KSF)。 面對潛在競爭者如中國大陸、日本、韓國、及印度IC設計業者急起直追的競局中，尤其是中國大陸挾帶廣大半導體IC產品需求、電子資訊產品的內需市場、充沛的人力、低廉的成本結構、加上政府政策的優惠獎勵措施及國際大廠的投資設廠，大陸IC設計公司以接近消費市場與擁有營運成本的優勢，將成為台灣IC設計業者未來最大的潛在競爭者。 半導體產業逐漸進入微利時代，台灣IC設計業者將面臨製造成本優勢不再，產業群聚的邊際效益正逐漸遞減中，企業為避免陷入價格戰，必須跳脫昔日以成本優勢為唯一考量的經營模式，在既有核心能力與競爭優勢的基礎上，試圖朝向提升產品與服務價值的方向發展，利用「營運模式創新」與「產品功能創新」來達到企業經營效率的提昇與附加價值的創造，朝價值鏈兩端的創新經營延伸，才能因應產業在全球化過程中，新興競爭者崛起所帶來的競爭威脅，建立企業之持久競爭優勢。 對於未來IC設計產業的發展方向有一、整合軟體、硬體、及IP技術的系統單晶片SoC產品發展；二、營運型態朝向策略聯盟之垂直似整合的合作模式；三、大者恆大的集團化趨勢；四、大陸市場崛起的商機掌握。台灣IC設計業者要在產業的垂直似整合中，利用既有的競爭優勢，締造未來市場雙贏的榮景。從企業的發展機會來看，市場上沒有絕對的競爭，只有無法掌握的機會。

本研究以針對B2B資訊系統設計之資訊系統成功模型(IS Success Model)作為假設架構，探討使用者滿意度與持續使用意願間的關係，並加入個人創新特質做為影響持續使用意願之假設，在研究架構中，分別探討資訊品質與系統品質與使用者滿意度的關係，以及使用者滿意度與個人創新特質分別對持續使用意願的關係。 本研究透過問卷法抽樣進行資料蒐集，選擇2010台北國際電子產業科技展之參展廠商作為研究對象，在回顧大量文獻與研究架構，並且排除無效問項後，進行問卷調查與分析，總共回收117份有效問卷，以PLS(Partial Least Squares)法進行分析後，得到以下結論： 使用者對於資訊系統的滿意度與系統品質及資訊品質呈現正相關，當資訊品質越高，也就是資訊系統產出的資訊之品質越好時；使用者滿意度會越高；當系統品質越高時，也就是資訊系統本身的特性越好時，使用者滿意度會越高。本研究更進一步發現，資訊系統持續使用意願受到使用者滿意度及個人創新特質影響，使用者滿意度與持續使用意願有正相關，滿意度越高時，持續使用的意願會越高；個人創新特質與持續使用意願也呈現正相關，當使用者之個人創新特質越強烈時，持續使用資訊系統的意願會越高。 / This research, based on the IS Success Model proposed by DeLone and McLean(1992), the B2B information system regarding the relationship between user satisfaction and continuance usage. Personal innovativeness was added to test its relationship with continuance usage. Within the hypothesized framework, the impacts of latent variables in system quality and information quality on user satisfaction are examined and tested, respectively. The research is conducted through sampling by a survey from companies attending the 2010 Taipei International Electronics Show. Of 121 samples collected, 117 are effective. By analyzing the samples with the PLS (Partial Least Squares) method, the research concluded the following: User satisfaction is positively influenced by system quality and information quality, which represents the characteristics of the information system itself and the form of information produced by the information system respectively. User satisfaction, together with personal innovativeness of the users, positively influence the continuance intentions to use the information systems.

當創新總是發生在不同專業領域的交界之處，團隊成員之間有效的知識互動便成為組織維持其競爭優勢的必要因素，因此為了持續創新，團隊成員必須克服不同專業領域所存在的知識邊界障礙，以便能夠整合團隊成員的知識與專長。在資訊系統的開發過程中，系統分析階段是觀察系統分析人員與使用者知識互動的最佳情境，因此本研究首先探索系統分析情境下影響互動雙方知識分享意願的前因，即創新氣氛與互動雙方的互動投入程度，並檢測這些因素之間的關係及影響。其次，本研究彙整四類邊界物件的內容，即語法的、語意的、實務的與隱喻的邊界物件，探討不同類別的邊界物件之間的關係及對專案創意的影響，並更進一步探究互動雙方的知識分享意願對各類邊界物件的影響。 研究樣本來自258位學生所扮演的系統分析人員及258位業界使用者，研究結果發現創新氣氛會同時影響系統分析人員與使用者的知識分享意願。當系統分析人員的互動投入程度越高，使用者的互動投入程度也會提高。使用者的互動投入程度會正向影響系統分析人員及使用者自身的知識分享意願；但是系統分析人員的互動投入程度卻對使用者的知識分享意願產生直接且負向的影響。 此外，系統分析人員的知識分享意願只對隱喻的邊界物件有正向影響，而使用者的知識分享意願卻對這四類邊界物件皆無顯著影響。在這四類邊界物件之中，只有實務的邊界物件對專案創意具有正向的影響，而隱喻的邊界物件則對於語法的、語意的、實務的邊界物件三者具有正向的影響，因此隱喻的邊界物件可以藉由實務的邊界物件對專案創意產生正向的間接效果。出乎意料之外，語意的邊界物件對專案創意具有負向的影響。在實務方面，本研究建議組織應該藉由增加實務的邊界物件和隱喻的邊界物件，以提高專案創意嶄露的可能性。 / As innovation happens from the boundaries between different specialty domains, effective knowledge interaction among participants has become a competitive necessity for organizations. In order to improve innovation, it is necessary for participants to deal explicitly with the interpretive barriers and further synthesize their expertise. During the development of information system, most knowledge interactions, which are conducted by systems analysts and users, can be observed in the phase of systems analysis. Thus, this study intends to explore not only factors that may affect participants’ intention to share knowledge, but also types of boundary objects in the context of systems analysis. As an innovative organizational climate and participants’ interaction involvement are identified as antecedents of participants’ intention to share knowledge, the relationships among these factors are studied. Besides, while four types of boundary objects are summarized, their effects on project innovativeness are discussed. Then, the influence of participants’ intention to share knowledge on the occurrence of four types of boundary objects was further examined. The results, based on data collected from 258 student analysts and 258 users, indicate that an innovative climate positively and directly influences both systems analysts and users’ intention to share knowledge. While systems analysts’ interaction involvement has a strong influence on users’ interaction involvement, which is measured by responsiveness, perceptiveness and attentiveness, users’ interaction involvement also has positive effects on both systems analysts and users’ intention to share knowledge; unexpectedly, systems analysts’ interaction involvement is negatively related to users’ intention to share knowledge. In addition, while systems analysts’ intention to share knowledge only influences the occurrence of metaphoric boundary objects, users’ intention to share knowledge does not demonstrate any significant effect on four types of boundary objects. Out of syntactic, semantic, pragmatic and metaphoric boundary objects, only pragmatic boundary objects had a strong positive effect on project innovativeness. As metaphoric boundary objects are shown to have positive effects on all other three types of boundary objects, metaphoric boundary object affects project innovativeness indirectly through pragmatic boundary objects. Surprisingly, semantic boundary objects negatively affects project innovativeness, although not very strongly. A practical implication is the possibility of increasing project innovativeness by enhancing both pragmatic boundary objects and metaphoric boundary objects.

面臨到現今社會的激烈競爭，服務創新是應付此環境變化的趨勢之一，但大部分台灣的中小企業主並不知道如何將服務創新實踐在他們的企業中。另一方面，大部分中小企業主並不清楚什麼是服務創新，即使知道服務創新可以改善他們的事業，也缺乏實踐的勇氣。因此，為了改善以上的情況，本篇論文的主旨是引用動機理論來建構小客製化的小故事廣告來激勵中小企業主，並讓他們明白服務創新的好處且有勇氣去實踐。為了達到這個目標，我們使用機率擴展有限狀態機(Probabilistic Extended FSM)作為實踐的方法，利用Dramatica的故事元素和十種創新類型的元素並以三幕劇來建構故事架構，在整合中小企業主的相關資料形成完整的激勵故事。從該激勵故事中，中小企業主可以得到一些啟示，改善岌岌可危的業務以實現他們心中的理想。 / Service innovation is one of the tendencies to cope with the environmental change in the current fierce competition, but the most SMEs in Taiwan don’t know how to put service innovation into practice in their business. On the other hand, the most SMEs don’t know what service innovation is; however, even they know service innovation could rescue their poor business; they have no courage to do so. For these reasons which mentioned above, the aim of this research is to reference the motivation theory and try to generate the mini customized advertising-like to stimulate SMEs and let them know the advantage of service innovation and have confidence to do so. In order to achieve this goal, we use Probabilistic Extended FSM as the implementation approach to integrate the private information of our target SMEs with the story framework which is constituted by the three-act Structure including the Dramatica elements and the elements of ten types of innovation. By this kind of stimulating mini customized advertising-like story, the SMEs could get some enlightenment to ameliorate the precarious business to achieve the ideal of their mind.

本研究架構以Wixom & Todd(2005)提出的使用者滿意與科技接受整合模式為基礎，以資訊系統成功模式中「系統品質」、「資訊品質」、「服務品質」構面以及Roger(1995)提出的創新擴散中「相對好處」、「相容性」作為研究架構的探討構面，針對雲端遊戲平台的使用者進行實證研究，探討使用者參與雲端遊戲平台之影響因素。 研究中，得知資訊系統成功模式「系統品質」、「資訊品質」、「服務品質」與「資訊系統滿意度」存在正向影響關係，創新擴散「相對好處」、「相容性」也與「資訊系統滿意度」呈現正向的影響關係；而資訊系統成功模式「資訊系統滿意度」與科技接受模式的「知覺有用性」、「知覺易用性」確實有著密切關連；另外，研究發現創新擴散構面對於「知覺有用性」存在影響關係，但對於「知覺易用性」證實不存在顯著的影響關係，而科技接受模式「知覺有用性」、「知覺易用性」、「態度」、「使用意圖」彼此皆存在影響關係。 / This study bases its structure on Theoretical Integration of User Satisfaction and Technology Acceptance Wixom & Todd (2005) proposed, in which “System Quality”, “Information Quality”, “Service Quality” dimensions in Information System Success Model, and “Relatively Advantage” & “Compatibility” in Innovation Diffusion that Roger (1995) proposed constitute discussion dimension. For discussing factors that influence users to take part in cloud gaming platform, the empirical research targets at those users. From the research, we found “System Quality”, “Information Quality”, “Service Quality” and “IS Satisfaction” in Information System Success Model have positive correlation, and “Relatively Advantage” & “Compatibility” and “IS Satisfaction” present a positive correlation as well while “IS Satisfaction” in Information System Success Model and “Perceived Usefulness”, “Perceived Ease of Use” in Technology Acceptance Model are closely related; besides, this study discovered Innovation Diffusion dimension has effect on “Perceived Usefulness”, but doesn’t have significant effect on “Perceived Ease of Use” while “Perceived Usefulness”, “Perceived Ease of Use”, “Attitude” and “Intention to Use” in Technology Acceptance Model are related.

企業著眼於國際市場機會進行國際化的同時，面臨到不同的阻礙，過去國際化的理論討論到影響國際化的速度、進入模式、國家選擇等的各種因素，但隨著產業的型態改變，以及進入國家的不同，國際化的歷程或是成功因素可能因而有所差異。因此，本研究欲探討電子商務在國際化的過程中，特別是進入新興市場國家時，由於電子商務尚未成為主要消費模式，電商企業的國際擴張將會受到哪些因素影響，不同於過去生產導向的國際化歷程，這些障礙又能夠如何被克服。過去學者曾討論外來者劣勢在企業國際化中的影響，但並沒有探討是否適用電商產業，由於產業特性的不同，以及母國市場與進入市場的差異，過去學者提出企業外來者的身份在新市場中面對外來者劣勢，然而，隨著電子商務產業的出現，亦有學者提出局外人劣勢才是新型網路企業在國際化中的主要劣勢，因此，本研究針對過去學者提出的從外來者劣勢（Liability of Foreignness）、局外人劣勢（Liability of Outsidership）出發，結合企業專屬優勢（firm-specific advantage）以及創新擴散理論（Diffusion of Innovations Theory），針對國內外共四家電商業者，採用深度訪談法歸納研究結果。研究結果發現雖然電子商務相較於一般企業在進行國際化初期，主要仍受到外來者劣勢影響，方能順利進入市場去處理身為局外人所帶來的劣勢，透過創新擴散理論的資訊溝通方式以及企業本身的專屬優勢，則可以有效降低進入所遇到的障礙，達到企業在東南亞市場成長的目標。 / During internationalization, firms seek growth opportunities in global markets, while being faced with various sources of obstacles and disadvantages. Previous researches and theories discuss the factors that influence the speed of internationalization, mode of entry, and country selection. However, with the change of industry, and the difference types of countries that are entered, the process of internationalization and the factors that influence the success might vary. As a result, the research aims at clarifying the variables that influence the internationalization of ecommerce corporations, especially when entering emerging markets. In the research, structured interviews were conducted to gain deeper understanding of the internationalization of 4 e-commerce firms. Our findings is that in emerging markets, e-commerce has not become the main stream; therefore, firms need to deal with both liability of foreignness and liability of outsidership because of the new technology and the role as a foreigner in the market. With the firm-specific advantages and the usage of online media and opinion leaders in the countries, e-commerce corporations are more likely to offset the liability that stems from foreignness and outsidership. However, the research shows that the liability of foreignness is more important and urgent for firms to overcome than liability of outsidership. Our research conceptualizes the framework for e-commerce internationalization and provides empirical evidence for the entry and growth in emerging markets.

本研究探討建構發展桌遊社群平台之營運模式及其關鍵成功因素，以形成執行策略與行動計畫。 本研究採文獻探討、深度參與、資料分析、探索性個案式研究，先以「SWOT矩陣分析」，來分析探討個案現況；再以「商業模式九宮格」以及「新創事業之精實商業模式十一格」兩者，來探討個案分析；之後，再以SWOT之分析結果，針對兩種宮格分析結果每一宮格之內容項目，再進行探討分析；也就是在兩種宮格分析後，每一格，再用SWOT去探討分析，由此呈現出更深入具體之執行策略與行動計畫。最後再輔以創新擴散模型來推論計算，各階段社群平台推廣之臨界數量與營運目標。終能更完整建構桌遊社群平台之營運模式，形成關鍵策略、競爭策略、行動策略等流程圖，並表列出各種行動方案之執行建議。 當手談趣在台灣成為會員數或開店數排名第一的桌遊社群平台之後，或可研究進入中國或全球之桌遊市場，探討中國或全球市場之桌遊社群平台營運模式；亦可考慮進入台灣、或中國、或全球之其他產業市場，進一步研究探討，台灣、中國、或全球市場其他產業之社群平台營運模式。 / This research tried to develop and complete the business model of table game online community platform also find out the key success factors of it, thus, we can form the executive strategy and action plans. This research used SWOT matrix to analyze the case situation, then used Business Model Canvas and Lean Canvas to examine the case analysis. Afterwards, we used the SWOT matrix to examine and analyze the Business Model Canvas and Lean Canvas by each canvas element again. Then, we used Innovation Diffusion Theory to calculate the critical mass and determine the quantitative objective of every stage. We can study on China or global market of table game online community platform or other industries via this research process after Sotanfun platform reaches success of the first or second stage of its quantitative objectives.

生物藥品是很多先前具致命性和難以治療的疾病領域，像是癌症、自體免疫疾病及神經系統疾病內最被看好的現行新穎療法。近年來，隨著探索出突破性小分子藥物愈趨困難，加上生物藥品在新藥研發過程中有較低的折損率與較高的成功產出率，使得越來越多藥廠紛紛轉向開發利潤豐厚的大分子生物產品。此外許多暢銷生物藥品專利期即將屆至，從而帶來對相對價廉、通常被稱為原廠生物藥品仿製版本之「生物相似性藥品」的龐大治療需求。然而，由於生物藥品和小分子藥物在分子大小及結構複雜程度方面存在截然不同的特性與本質差異，因此建立一套專屬於生物相似性藥品的上市許可規範勢在必行。 作為於2010年3月23日正式簽署公告之「患者保護及可負擔照護法案」中的一部分，美國國會通過了「生物藥品價格競爭與創新法」(BPCIA)。BPCIA的生效被視為製藥產業最重要的變革之一，旨在藉由競爭達到維護公眾健康、促進生物技術創新和控制醫療支出之目的，同時取得適當之三方利益平衡。BPCIA即以Hatch-Waxman法案下的化學學名藥核准途徑為模版，創建生物藥品簡易上市申請程序。 本論文的結構主要區分為兩大部分進行研究，其一提供了製藥產業概觀與全球生物藥品市場的發展趨勢，其二則聚焦在BPCIA新建立的核准前專利爭端解決程序下，生物相似性藥品面臨「專利舞蹈」時的法律評估及智慧財產權管理。 論文的第一部分係根據從各種市場研究報告收集、整理而成的統計數據，以系統性的方式深入介紹全球製藥產業，並分析生物相似性藥品的市場機會和潛在隱憂。另外此部分亦詳細說明了生物相似性藥品的生理活性、知識斷層與製程依賴性之間的關係、分析技術對生物產品做完整定性的不足以及生物相似性藥品的開發流程。 論文的第二部分則以討論BPCIA的重要條文規定為主，包括專利舞蹈制度和上市審查要求，諸如生物相似性之證明、可互換性之認定與適應症外推。其他相關議題，包含參考藥品的法定專屬權保護期長度、生物相似性藥品自動替換之立法化、專利資訊交換機制的可能濫用及原廠與生物相似藥廠達成反競爭協議之風險皆會予以進一步探討。除此之外，本部分也介紹了歐盟和台灣生物相似性藥品上市法規的沿革與現況。 本文試圖透過對生物相似性藥品的全方位綜合研究成果，提出可行的市場進入方案及善用專利和營業祕密優勢之智慧財產權保護佈局策略。 / Biologics represent many of the most promising novel therapies for previously deadly and intractable disease areas like cancer, autoimmune disease and neurological disorders. As discovery of breakthrough small-molecule drugs becomes more difficult, together with lower attrition rate and higher productivity of biologics in the new drug research and development (R＆D) process, pharmaceutical companies are increasingly turning to develop lucrative large-molecule biological products in recent years. In addition, the patents on numerous blockbuster biologics treatments will soon expire, bringing soaring demand for relatively inexpensive generic versions of originator biologics, generally known as “biosimilars.” However, due to contrasting characteristics and natural differences in terms of size and structural complexity between biologics and small-molecule drugs, it is necessary to create a regulatory pathway solely for biosimilars. As part of the Patient Protection and Affordable Care Act which was officially signed into law on March 23, 2010, the U.S. Congress passed the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA is considered one of the more significant overhauls to the pharmaceutical industry, aiming to strike a proper balance among securing public interests, stimulating biotechnology innovation and controlling healthcare expenditure through competition. It established an abbreviated approval pathway for biosimilars modeled closely after the Hatch-Waxman Act’s approval process for generic chemical drugs. The structure of this thesis is divided into two major parts, of which the first part provides an overview of pharmaceutical industry and trends in the global biologics market, whereas the second part focuses on the legal assessment and intellectual property management of biosimilars under BPCIA’s new pre-approval patent dispute resolution process, the “patent dance”. The first part starts from the in-depth systematic introduction of global pharmaceutical industry based on statistics collected from various market research reports, then analyzes the market opportunities and potential concerns for biosimilars. Moreover, this part illustrates the physiological properties, the relationship between “knowledge gap”and manufacturing path-dependence, the insufficieny of analytical techniques in fully characterizing biological products, and the development process of biosimilars in details. The second part discusses key provisions of the BPCIA, including the patent dance procedures and regulatory requirements, such as demonstrating biosimilarity, interchangeability and extrapolation. Other relevant issues include the length of statutory exclusivities granted to reference products, legislations on biosimilar automatic substitution, potential abuses of patent information exchange mechanism and risks of reaching anti-competitive agreements between pioneers and biosimilar manufacturers will be further discussed. Besides, this part describes the timeline and status quo of EU and Taiwan’s biosimilar approval regulations. With comprehensive study on multiple aspects of biosimilars, this article tries to propose feasible market access plans and robust intellectual property protection strategies capitalizing upon patents and trade secrets.