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FDA Releases Draft Question and Answers Guidance on Interchangeable…
In late 2020, the United States Food and Drug Administration (FDA) issued a draft set of four questions and answers guidance that…
AbbVie Notches Major Victory in Antitrust Suit
Earlier this summer, Judge Manish Shah of the United States District Court for the Northern District of Illinois dismissed a…
Biosimilars Could Save Taxpayers Billions
A recent analysis conducted by Pacific Research Institute and Wayne Winegarden, PhD, found that if biosimilars reached 75% market…
FDA Releases Draft Guidance on Biosimilar Review
Earlier this month, the United States Food and Drug Administration (FDA) issued new draft guidance on how it plans to expedite its…
FDA and FTC Join Forces on Biosimilar Marketing
Earlier this month, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) released a joint statement about…
High Expectations For New Biosimilars About to Hit Market
With recent concerns about the skyrocketing cost of prescription drugs and biologics, attention has turned to whether the…
Biologic Exclusivity Provision Removed from USCMA Agreement
5Recently, officials from the United States, Mexico, and Canada signed a new United States-Mexico-Canada trade agreement (USMCA).…
Study demonstrates impact of CME activities on clinician awareness of…
The outcomes of a recent continuing medical education (CME) program demonstrated that prior to the participating in the education…
FDA Final Guidance on Demonstrating Biosimilar Interchangeability
The FDA issued a final guidance on the pathway for interchangeable biosimilar drugs. The guidance is intended to assist sponsors…
Is FDA Guidance on Biosimilars Unconstitutional?
Drug makers and trade groups have recently raised questions regarding a United States Food and Drug Administration (FDA) guidance…