COMMERCIAL STRATEGIES FOR THE INNOVATOR AND BIOSIMILARS MARKETPLACE
GLOBAL STRATEGIES: From Patent Protection to Cost and Market Access
Goodwin Procter LLP
Honorable Teresa Rea
Crowell & Moring LLP
(Former Acting Director of the United States Patent and Trademark Office)
Biosimilars and innovator biologic markets and their regulation have steadily evolved in Europe and the United States, with the European marketplace experiencing the most commercial success. As pharmaceutical drug pricing continues to attract global scrutiny and political pressure, a growing number of potentially cost-saving drugs are in the pipeline.
Not far behind, and thanks to a favorable regulatory environment, the Chinese biosimilar marketplace is booming. Although the regulatory approaches are similar in general scientific content, certain key differences have amplified acceptance and market growth in China relative to the United States and Europe. This session will contemplate what is next for biosimilars in established markets like Europe, and emerging markets like China.
- Assessing regulatory and legislative developments impacting the biopharmaceutical industries in each region
- Understanding the economics and market influences
- Considerations for market access, sustainable pricing and reimbursement policies.
- Market uptake of biosimilar products.
- Biosimilar v. biosimilar litigation in a crowded market