News & Analysis as of

European Union › Biosimilars › Drug Pricing

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
A&O Shearman

Council position on EU pharma package adopted

A&O Shearman on

On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more

Hogan Lovells

EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights

Hogan Lovells on

On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more

Goodwin

Sandoz Launches PYZCHIVA® (Ustekinumab) Autoinjector in Europe

Goodwin on

On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.”...more

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

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated May 2, 2025

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

FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025....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

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

Sheppard Mullin Richter & Hampton LLP on

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more

Goodwin

Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

Goodwin on

As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year...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

Haug Partners LLP

INSIGHT: Abbvie Defeats Novel Antitrust Claims Against Humira Patent Estate—Lessons Learned

Haug Partners LLP on

A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Goodwin

European Commission Releases Pharmaceutical Anti-Competition Report

Goodwin on

The European Commission has released a report summarizing the European Commission and the national competition authorities’ work to enforce European Union antitrust and merger rules in the pharmaceutical space. The report...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2018

Hogan Lovells on

Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

Goodwin

USP Says European Market Shows Mandatory USP Standards Would Improve Biosimilar Approval, Acceptance in U.S.

Goodwin on

Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance...more

Goodwin

IMS Health Report “The Impact of Biosimilar Competition” is Released

Goodwin on

Last week, IMS Health released a report entitled “The Impact of Biosimilar Competition”. The report is an update of an earlier May 2015 report that noted that biosimilar uptake could save European and American health systems...more

14 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide