HighPoint Blog

On July 18, 2018, the FDA published its guidance for biosimilars, “Labeling for Biosimilar Products.” This guidance provides an overview of the FDA’s recommendations for biosimilar labeling, so that prescribers can make informed decisions. The FDA states the intent of the guidance is to help manufacturers “develop draft labeling for proposed biosimilar products for submission in an application...

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Biosimilars are on the agenda of several players in the pharmaceutical industry. Several companies’ new leg of growth seems to be the creation of a biosimilar franchise. The question is “How real are the opportunities in an ever growing competitive environment?"

In the next 5 years, Biosimilars could hit the market to compete with some key biologics cumulating sales of more than EUR40 billion....

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