Aydin Harston Ph.D.

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

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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

3/16/2022 / Biosimilars , BPCIA , Center for Drug Evaluation and Research (CDER) , Drug Pricing , European Medicines Agency (EMA) , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

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

11/16/2021 / Biologics , Biosimilars , BPCIA , Center for Drug Evaluation and Research (CDER) , Drug Pricing , European Medicines Agency (EMA) , Food and Drug Administration (FDA) , Pharmaceutical Industry

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

- FDA has not approved any biosimilars in 2021 after only approving three in 2020. - EMA approves second Novolog® (insulin aspartate), fifth Avastin® (bevacizumab), eighth Neulasta® (pegfilgrastim), and twelfth Humira®...more

3/9/2021 / Biologics , Biosimilars , BPCIA , Center for Drug Evaluation and Research (CDER) , European Medicines Agency (EMA) , Food and Drug Administration (FDA) , Pharmaceutical Industry , Public Health Service Act

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

• FDA has only approved two biosimilars in 2020. • No biosimilars have launched in the U.S. since April 2020. • EMA approves first Novolog® (insulin aspartate), third and fourth Avastin® (bevacizumab), and sixth Herceptin®...more

10/13/2020 / Biologics , Biosimilars , BPCIA , Center for Drug Evaluation and Research (CDER) , Food and Drug Administration (FDA) , Pharmaceutical Industry

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