Newsletter - July 29, 2021
FDA’s First Interchangeable Biosimilar: Floodgate for Others?
Yesterday’s approval of the first interchangeable biosimilar by the FDA provides a proof of the concept for biosimilars that will be treated like generic drugs in that they can be substituted for the reference product at the pharmacy without needing a specific prescription. This is a major milestone that has been almost 10 years...Read More
Is FDA Taking Too Long to Approve the Covid Vaccines?
With 343 million doses administered and 163 million people fully vaccinated in the US, it may be annoying for the layman as to why has FDA not yet fully approved any vaccine. And it would not be an unreasonable question to ask, although probably unfair to the FDA. It is important to understand a few other numbers to put this in context...Read More
FDA’s First Interchangeable Biosimilar: Floodgate for Others?
Yesterday’s approval of the first interchangeable biosimilar by the FDA provides a proof of the concept for biosimilars that will be treated like generic drugs in that they can be substituted for the reference product at the pharmacy without needing a specific prescription. This is a major milestone that has been almost 10 years...Read More
Is FDA Taking Too Long to Approve the Covid Vaccines?
With 343 million doses administered and 163 million people fully vaccinated in the US, it may be annoying for the layman as to why has FDA not yet fully approved any vaccine. And it would not be an unreasonable question to ask, although probably unfair to the FDA. It is important to understand a few other numbers to put this in context...Read More
