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Generic Drugs: The Global Market: Focus on the Americas
Date:9/21/2011

UGH 2016 ($ BILLIONS) 10

RECENT HISTORY OF THE GENERICS SECTOR 11

ROCHE-BOLAR 11

Roche-Bolar (Continued) 12

GENERICS LOBBY 13

ICH 14

CHAPTER FOUR: THE NEW GENERICS ERA 15

THE PATENT CLIFF 16

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

US 29

TABLE 4 REQUIREMENTS FOR NDA AND ANDA APPLICATIONS 30

US (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 US 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 CERTIFICATE
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