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478,95 kr. This Case Study defines the global pharmaceutical industry and its boundaries"e;, analyses the profitability/attractiveness of the global pharmaceutical industry by using M.E.Porters' Five-Forces-Model and answers the questions what overall industry trends can be identified and how the profitability/attractiveness of the industry will change in the future. Furthermore, it explains and evaluates Pfizer's new strategy and examines what Pfizer did in the recent years to maintain their profitability.
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638,95 kr. Globalization and regionalism are two theories in International Relations which are now abuzz. These two terms have impacted the East African Community as a regional integration unit within the African continent. Originally, the EAC only had three member nations and they encountered political turbulence, which disrupted its cohesion in the 1960s and 1970s. The Mediation Agreement gave it a lifeline. Upon its revival, globalization and regionalism implicitly and explicitly became the guiding factors which guided and still guide the ¿new¿ EAC. It now has an expanded membership of seven neighboring nations. The EAC is one of the fastest growing sub-regional economic integration units in Africa and in the world. The analysis extrapolates how globalization and regionalism have impacted the globe and corroborates some factors with what is happening in the EAC sub- region in recent times.
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- RIFT-LINES WITHIN EUROPEAN REGULATORY FRAMEWORK FOR BIOSIMILARS WHEN TAKING HETEROGENEITY AND VARIATION DURING LIFECYCLE OF THE REFERENCE BIOLOGIC AND THE BIOSIMILAR INTO ACCOUNT
1.813,95 kr. Biopharmaceutical medicinal products (biologics) represent a huge financial market. Thus upon patent protection expiry of the innovator (reference) biologic there is interest from industry to gain a portion of this market by launching a 'similar' biologic at a reduced development cost, thus boosting potential gains. The EMA responded to this desire and lead the guidance process with industry on the topic of biosimilars. Based on the experience gained with biosimilars in the past, the EMA started to introduce a second generation series of guidance documents, which take into account the past, current and possibly future challenges of biosimilars. Those proposals were evaluated by EMA and partially incorporated into new guidance documents. This work highlights the challenges and risks associated with biosimilar submissions for large and complex bio-molecules such antibodies. Results: There are unaddressed questions for the regulator with regard to the unsolved dynamic of heterogeneity and variations of the quality profile, which have potential implications on safety and efficacy. This is neglected and not taken into account seriously enough by the stakeholders. Solution: Further, the only (in my view) progressive way to deal with such foreseeable situations from the biosimilar developer's point of view is to incorporate a design space.
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