Gaps in Global Standards Threaten Biosimilars Development

September 28, 2014

Although progress has been made in bringing biosimilars to market, gaps in requirements for testing and documenting product similarity are still hampering the EU, U.S., and other regions, writes Jill Wechsler.

Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions.

For more on this article by Jill Wechsler, click here.

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