Abstract

The thesis examines the government regulatory policy towards the pharmaceutical biotechnology sector (Biopharmaceutical), with focus on Similar Biotherapeutic Products (biosimilars). Biosimilars are highly similar but not identical molecules that claim to have similar quality, safety and efficacy of original (innovator/ reference) products. They differ significantly from the chemical based medicines (conventional pharmaceuticals) that the main active substance is usually from a living organism (biological). Such critical products are high on the treatment guidelines recommended for complex diseases with high death and disability burdens. Biosimilars started accessing the Egyptian Market long time before the Government established a proper regulatory structure/pathway to regulate such products. It is expected that Biosimilars will start accessing the Egyptian market with high influx rate during the upcoming years as many originator biopharmaceuticals are losing patent protection between 2013-2020. Such influx requires progressive policy thinking and well-resourced regulatory structures to properly regulate the complex pharmaceutical biotechnology market, ensure protection of public health, prevention of potential regulatory failures and promoting investment in local production for improving access to medicines. The thesis adopts a qualitative methodology using semi structured and in-depth interviews with experts from the concerned governmental regulatory agencies, the biopharmaceutical industry, special interest groups (lobbying bodies), clinicians, civil society and independent researchers. Analytical findings revealed potential for regulatory reforms and policy options were suggested across the three regulatory domains studied (regulatory pathway of biosimilars , pricing policy and intellectual property protection).

Department

Public Policy & Administration Department

Degree Name

MA in Public Policy

Graduation Date

6-1-2013

Submission Date

January 2013

First Advisor

Ali, Hamid PhD

Committee Member 1

Abdelfattah, Moataz PhD

Committee Member 2

Azzazy, Hassan PhD

Extent

114 p.

Document Type

Master's Thesis

Library of Congress Subject Heading 1

Medicine -- Egypt.

Library of Congress Subject Heading 2

Drugs -- Law and legislation -- Egypt.

Rights

The author retains all rights with regard to copyright. The author certifies that written permission from the owner(s) of third-party copyrighted matter included in the thesis, dissertation, paper, or record of study has been obtained. The author further certifies that IRB approval has been obtained for this thesis, or that IRB approval is not necessary for this thesis. Insofar as this thesis, dissertation, paper, or record of study is an educational record as defined in the Family Educational Rights and Privacy Act (FERPA) (20 USC 1232g), the author has granted consent to disclosure of it to anyone who requests a copy.

Institutional Review Board (IRB) Approval

Approval has been obtained for this item

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