選擇自行研發或爭取授權開發學名藥之決策流程

A Study on the Decision-Making Flow for Choosing Between Self-Development and Authorized Development of Generic Drugs

鄭莉瑩(Li-Ying Cheng)

指導教授 ： 周雍強

國立臺灣大學/工學院/工業工程學研究所/碩士(2021年)

https://doi.org/10.6342/NTU202101221

摘要

過去，「授權學名藥」（Authorized Generic, AG）被視為專利藥廠削減學名藥挑戰專利意願、阻止first-filer進入市場的武器，但近年來，專利藥廠與學名藥廠的合作時有所聞，專利藥廠與學名藥廠之間的授權實例逐漸增加，專利藥廠與學名藥廠的競合變得更加多元。「授權學名藥」應可成為學名藥廠在自行以逆向工程研發藥品以外的另外一種策略選擇。
然而，台灣製藥產業中的授權學名藥並不常見，因此在以學名藥廠觀點出發的相關研究中，尚未有充分的解釋，或很少被檢視。本研究之目的，在於探討學名藥廠在何種條件下可選擇與專利藥廠策略結盟，選擇上市「授權學名藥」，並且運用設計結構矩陣（Design Structure Matrix, DSM）來改善評估流程。
本研究經整理歸納文獻後，提出可行性決策假說模型，將開發標的藥品依照技術可行性與市場可行性分類為四個象限。第一象限之藥品可視原廠品牌力效果高低，選擇「授權學名藥」策略或自行開發；第二象限之藥品應選擇「授權學名藥」策略；第三象限之藥品不予開發；第四象限的藥品則選擇自行開發。
公司在使用模型決策前，須先進行可行性評估工作。評估工作的流程順序繁雜，可先使用設計結構矩陣分析來進行流程精簡與改善後再執行。經過評估，公司可得知開發標的藥品在可行性決策模型上的最終落點，進而做出最終決策。期待此假說模型及運用DSM改善流程的方式能作為學名藥廠的未來參考，建議未來相關研究能補足此假說模型之不足，並精進流程管理上Domain Mapping Matrix （DMM）與Multi Domain Matrix（MDM）的相關應用。

關鍵字

授權學名藥 ； 設計結構矩陣

並列摘要

In the past, “Authorized Generic” (AG) was regarded as a weapon for innovator companies to reduce the willingness of generic drug companies to challenge patents and prevent first-filers from entering the market. However, in recent years, more and more cooperation between brand-name and generics manufacturers were announced, and the number of authorized licensing projects between innovator companies and generic drug companies has gradually increased, it means the competition and cooperation between innovator companies and generic drug companies have become more diverse. "Authorized generic drugs" should be taken into consideration as another strategic choice for generic drug companies to develop drugs other than self-development.
In the pharmaceutical industry in Taiwan, authorized generic drugs are not common. Therefore, the related studies from the viewpoint of generic drug manufacturers have not been sufficiently explained or even reviewed. The purpose of this study is to explore the conditions under which generic drug companies can choose to strategically form alliances with innovator companies to market "authorized generic drugs", and to recommend the use of Design Structure Matrix (DSM) to improve the evaluation process.
After reviewing and summarizing the literature, this study proposes a feasibility decision-making hypothesis model, and classifies the development target drugs into four quadrants according to technical feasibility and market feasibility. For drugs in quadrant I, after weighing the brand power effect of the originators, generic drug companies can choose between the strategy of "authorized generic drugs" and self-development; for drugs in the quadrant II, companies should select the strategy of "authorized generic drugs"; for drugs in the quadrant III, they shall not be developed; and for drugs quadrant IV, companies shall choose to develop on their own.
Before the company uses the model to make decisions, it must first conduct a feasibility assessment. Since the process of the assessment is complicated, the company can use DSM analysis to improve the process flow before execution. After the assessment, the company obtains the positioning of the target drug to develop on the feasibility decision model plot, and then make the optimal decision.
It is hoped that this hypothetical model and the application of DSM to improve the process flow can be regarded as a future reference for generic drug companies. It is recommended that future related studies can complement the deficiencies of this hypothetical model, and extend the applications of Domain Mapping Matrix (DMM) and Multi Domain Matrix (MDM) in process management.

並列關鍵字

Authorized generic drugs ； Design Structure Matrix

參考文獻

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