in the U.S. and Europe.481 The Patient Protection and Affordable Cure Act, enacted in 2010, establishes a 12 year period of data exclusivity for new biological drugs between the date of FDA approval and the filing date for biosimilar approval based on the innovator’s original data, a measure which may inhibit the introduction of biosimilars.
The global competitive environment is being shaped to an important degree by the national policies of our competitors. This chapter has explored the major policy issues affecting the competitiveness of the semiconductor, photovoltaic products, advanced batteries, and pharmaceuticals industries. Each of these industries can be regarded as strategic to the United States. While many nations in Europe and Asia use the full force of government to attain commercial competitive advantage in industries they regarded as strategic, the idea of proactive government help for private industry in the name of economic development has sometimes raised concerns in the United States about distorting market forces and the wisdom of letting public servants “pick winners.” In reality, the U.S. federal government has long played an integral role in the early development of numerous strategic industries, not only by funding research and development but also through financial support for new companies and government procurement.
Each of the four industries studied face unique circumstances and challenges. At the same time, they illustrate the important role that national investments have played in supporting their development and the need for public policies to ensure that the nation captures the benefits of these investments in terms of economic growth and high value employment.
481 In the U.S. the Biologics Price Competition and Innovation Act of 2009 was enacted in 2010 to create a shortened path to regulatory approval for biosimilars. The FDA is currently developing guidelines for the approval process for biosimilars. As of March 2012 it had not yet received its first biosimilars application. “Fitch Looks at Implications of FDA Biosimilar Guidance,” Pharma Times (February 13, 2012).