A comprehensive guide to the three biosimilar markets (Europe, US, Japan) and the regulatory pathways
Name
726650223-MIT.pdf
Description
Full printable version
Size
12.16 MB
Format
Adobe PDF
Checksum (MD5)
a62c5fac7d8e5f00d0dc897ae7db6df6
Author(s)
Patrawala, Zeenat (Zeenat J.)
Advisor(s)
Fiona Murray and Gary Pisano.
Date Issued
2010
Publisher
Massachusetts Institute of Technology
Abstract
Generics in the pharmaceutical industry have been instrumental in reducing overall healthcare cost and allowing for greater dispersal of life saving drugs to the general population. The Hatch-Waxman Act of 1984 played a critical role in changing the landscape of the pharmaceutical industry and providing legislation for an abbreviated regulatory pathway for generic drugs. The conversation has shifted to the need to implement similar regulatory paths for generics of biologics. First generation biologic patents have or are geared to expire within the next five years, providing a great opportunity for generic companies in this space to enter. Biologic generics, termed biosimilars or follow-on biologics, are more difficult to evaluate due to the complex nature of the molecule and the variables involved in the development and manufacturing process. This research seeks to understand the current debate in the biosimilar conversation, and examine whether there is a clear regulatory path to market for biosimilars using epoetin as a case example across the three main markets; US, Europe and Japan.
Description
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2010.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 57-59).
Subjects
Harvard University--MIT Division of Health Sciences and Technology.
MIT Department
Harvard University--MIT Division of Health Sciences and Technology
Terms of Use
M.I.T. theses are protected by
copyright. They may be viewed from this source for any purpose, but
reproduction or distribution in any format is prohibited without written
permission. See provided URL for inquiries about permission.
copyright. They may be viewed from this source for any purpose, but
reproduction or distribution in any format is prohibited without written
permission. See provided URL for inquiries about permission.
Persistent DSpace Link
