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European Medicines Agency (EMA) Drug Pricing

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

Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

Goodwin on

On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia....more

Venable LLP

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

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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

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

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline (Updated)

FDA and EMA both approve first biosimilar version of Lucentis® (ranbizumab). FDA has approved only two biosimilars in 2021 after only approving three in 2020. EMA approves four more Avastin® (bevacizumab) biosimilars,...more

Smart & Biggar

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

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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

Smart & Biggar

Rx IP Update - June 2019

Smart & Biggar on

National Pharmacare Update: Publication of the final report of the Advisory Council - On June 12, 2019, the Minister of Health tabled the final report, A Prescription for Canada: Achieving Pharmacare for All, from the...more

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