How “Consumer Reports” FDA Approvals Could Hurt Biosimilars

A recently published article in The Wall Street Journal proposes several changes to the FDA approval process. However, at a time when there should be more emphasis on accelerating biosimilar approval, this proposal very well could spell trouble for biosimilars. 

Amgen, Sandoz Biosimilar FDA AdComs: 5 Takeaways

Though both FDA advisory committees unanimously recommended approval and extrapolation of both Amgen's and Sandoz's biosimilars, this process was not as cut-and-dried as expected following the overwhelmingly positive FDA briefing documents. The stumbling points of each committee are important to note prior to your own candidates' FDA submission. 

Post-Brexit: The U.K. Biosimilar Market

In recent weeks, the U.K. made the seismic decision to leave the E.U. But biosimilars aren’t without support. Prior to Brexit, the U.K. celebrated the launch of the BBA, which has several initiatives underway to keep biosimilars a priority in the newly independent country.

Will Teva’s Play Usher Generic, Biosimilar Makers Into “Innovator” Territory?

PhRMA is facing a controversial, potentially industry-altering decision. The generics king Teva has requested to become a member of the trade organization that traditionally represents “innovators”. Could this move redefine the industry's perception of "innovation"?

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  • The 5 Basic Tenets Of Data Integrity — And How Failures Occur

    It amazes me that, with all the data integrity issues highlighted in regulatory agency inspections over the last several years, very few people I talk with today are familiar with the court case that set the legal precedent for data integrity standards.  To me, this is one of the reasons why we see so many data integrity issues — those who forget the past are condemned to repeat it.

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