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Prescription Drugs Drug Pricing European Medicines Agency (EMA)

Goodwin

EMA Adopts Positive Opinions for Multiple Biosimilars

Goodwin on

In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. ...more

Venable LLP

Senator Mike Lee Introduces the Biosimilar Red Tape Elimination Act to Eliminate Switching Study Requirement for Biosimilar...

Venable LLP on

On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more

Rothwell, Figg, Ernst & Manbeck, P.C.

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline Updated March 14, 2022

FDA and EMA both approve additional biosimilar versions of Humira® (adalimumab). FDA also approves its third biosimilar version of Neupogen® (filgrastim). ...more

Smart & Biggar

Canadian Institute for Health Information (CIHI) and Patented Medicine Prices Review Board (PMPRB) report upward trend of...

Smart & Biggar on

CIHI: On December 17, the Canadian Institute for Health Information (CIHI) published statistics on drug spending, finding that in 2018, around 40% of drug spending was spent on 2% of beneficiaries. Out of this 2%, three out...more

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