News & Analysis as of

Pharmaceutical Industry FDA Approval European Medicines Agency (EMA)

Goodwin

Teva’s Denosumab Biosimilar Candidate is Accepted for Review by FDA and EMA

Goodwin on

On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a...more

Goodwin

STADA and Alvotech Announce Launch of UZPROVO® in Europe

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​​​​​​​On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved...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

Goodwin

Biosimilar Market Updates

Goodwin on

Shanghai Henlius biosimilar antibody developments - On March 9, 2020, Shanghai Henlius Biotech, Inc. announced that its investigational new drug application has been accepted by China’s National Medical Products...more

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

Hogan Lovells

New drug marketing applications: how do EMA and FDA compare?

Hogan Lovells on

A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more

Wilson Sonsini Goodrich & Rosati

2018 Life Sciences Securities Litigation Roundup

2018 Filings - Companies in the life sciences industry, including biotechnology, medical devices, and pharmaceuticals, have long been favorite targets of securities class actions, and 2018 was no exception. According to a...more

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