Why are generic drugs the ‘same’ and biosimilars only ‘similar’ to their...
It’s the law and science. The regulatory world of biological drugs is more complex and perhaps less clear than for the world of small molecule drugs. This is particularly true in the U.S. where, for...
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If you missed the Maximizing Patent Life Cycles panel discussion, you may...
I recently participated in the American Conference Institute panel discussion “Maximizing Patent Life Cycles,” which was moderated by Pfizer Associate General Counsel Geoffrey Levitt. In case you...
View ArticleGPhA Petitions FDA Not to Distinguish Biosimilars by Unique Non-Proprietary...
The Generic Pharmaceutical Association requests that the U.S. Food and Drug Administration assign the same non-proprietary name to a biosimilar as the one held by its reference biologic. FDA has not...
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