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Generic Drugs: The Global Market
Date:9/21/2011

TABLE 2 FIRST PATENT EXPIRIES, 2012–2023 .. 17

TYPES OF GENERICS 17

"SIMPLE" GENERICS ... 17

Factors Influencing the Success or Failure of Generics . 18

Adequate Market Size .. 18

Patent-Expired Therapies 18

Older Products Still Used . 19

Long-Term Use . 19

Straightforward Production Technology .. 19

Drugs Used in Primary Care 20

SUPERGENERICS 20

BIOSIMILARS 21

Biosimilars (Continued) .. 22

TABLE 3 BIOLOGICS FACING THE LAUNCH OF BIOSIMILARS,

2001–2006 ... 23

Special Challenges ... 24

Special Challenges (Continued) .. 25

The Biosimilar Market 26

Some Biosimilar Developments and Introductions 26

EPO ... 26

G-CSF 26

Interferons . 26

HGH .. 27

Monoclonal Antibodies .. 27

Monoclonal … (Continued) 28

MAJOR GENERIC ISSUES . 29

REGULATORY ENVIRONMENT . 29

U.S. ... 29

TABLE 4 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS . 30

U.S. (Continued) .. 31

European Union ... 32

EU Marketing Authorization Systems 32

• The Centralized Procedure .. 33

• Decentralized and Mutual Recognition

Procedures. 34

• Mutual-Recognition Procedure ... 34

Types of Applications 35

• Applications Under Article 10 (Generic

Products) ... 35

Japan 36

Approval (Shonin) of Pharmaceuticals 37

REGULATION OF BIOSIMILARS ... 37

EU Provisions .. 38

Evolving Situation in the U.S. 39

Hatch-Waxman and Bolar ... 39

Defensive Strategies by "Big Pharma" ... 40

"AUTHORIZED GENERICS" 41

User Fees . 42

A "Mood Swing" Toward Generics .. 43

The Situation in Europe .. 44

PATENTS AND IP 45

SUPPLEMENTARY PROTECTION CERTIFICATES 46

Supplementary Protection Certificates (Continued) .. 47

CHAPTER FIVE: THE GLOBAL PHARMACEUTIC
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