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Multi-therapy Drugs: Opportunities for Generics & Biosimilars
Date:11/2/2011

topic of discussion. In the meantime, companies are hedging their bets and conducting comparative studies of their biosimilar MAbs in more than one indication.

About the Author

The report has been researched and written by Espicom Senior Analyst, Karen Holmes. Karen has over 15 years pharmaceutical and healthcare market analysis experience. Her recent studies include:

Hospital Injectable Drugs: Future Prospects for Generics and Biosimilars

Emerging Opportunities in Inhalation and Nasal Spray Generic Drugs

Ophthalmology Drug Futures.

Contents

FOREWORD .... 1

EXECUTIVE SUMMARY .. 3

OVERVIEW ...... 5

Lifecycle Development and New Indications ....... 5

Realising Additional Sales Potential .. 7

Rituximab: Multiple Indications from Oncology to Immunology ..... 8

Sildenafil: One Active Ingredient, Two Distinctly Branded Indications ... 9

Generic and Biosimilar Opportunities ..... 9

Biosimilar Approval for Multiple Indications: Extrapolation or Additional Trials? ..... 10

US Patent Expiries ..... 11

PRODUCT ANALYSIS ... 12

ANTI-METABOLITES .... 13

Alimta (pemetrexed) ... 13

Mode of Action ... 13

Approvals ..... 13

Lifecycle Development ... 14

Competition within the Marketplace . 14

Patents .. 15

Generic Company Activity ..... 15

Market Outlook .. 15

Xeloda (capecitabine) . 17

Mode of Action ... 17

Approvals ..... 17

Lifecycle Development ... 19

Competition within the Marketplace . 19

Colorectal Cancer ...19

Breast Cancer ..19

Gastric Cancer .20

Patents .. 20

Generic Company Activity ..... 20

Market Outlook .. 20

MONOCLONAL ANTIBODIES ... 22

Rituxan/MabThera (rituximab) 22

Mode of Action ... 22

Approvals ..... 22

Lifecycle Development ... 24

Competition within t
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SOURCE S .... 104
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