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Generic Drugs: The Global Market--Focus on Europe
Date:9/22/2011

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 CERTIFICATES 46

Supplementary Protection Certificate
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