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Gaps in Global Standards Threaten Biosimilars Development
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.
Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya Regimen for Ulcerative Colitis
November 22nd 2024Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.
