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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 -
Goodwin

Update on Recent International Biosimilar Approvals - September 2024

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Approval of Celltrion’s Ustekinumab Biosimilar in the EU:  On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA...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

The First Biosimilar Disputes at the Unified Patent Court (UPC)

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As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

Goodwin

Biosimilar Approval Updates in Europe and China

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On April 25, 2024, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion, recommending the granting of marketing authorization for Biogen Netherlands B.V.’s biosimilar TOFIDENCE (tocilizumab),...more

American Conference Institute (ACI)

[Event] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

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Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more

Goodwin

Update on Recent International Biosimilar Approvals

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​​​​​​​Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU:  On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar...more

Goodwin

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

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

A&O Shearman

The Collision Of Biologics – Emerging Competition And What To Expect

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On 11 March 2021, GCR hosted a series of interactive webinars. Our global co-head of antitrust, Elaine Johnston, participated in the panel that looked at the development of biologics and the role that antitrust has to play in...more

Haug Partners LLP

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

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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

Smart & Biggar

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

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In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

Hogan Lovells

EU SPC Manufacturing Waiver Now in Force

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The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469).  The Waiver has been introduced with the stated aim of putting EU generic and...more

Goodwin

Year in Review: Top 5 Foreign Market Developments in 2018

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Here are our picks for the top-five most significant foreign biosimilar market developments in 2018: 1. Shake-up In Europe’s Adalimumab Market - As a result of litigation and resulting global settlements, several...more

Goodwin

AbbVie Grants Momenta Global Patent Licenses for Biosimilar of HUMIRA (Adalimumab)

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Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira®...more

Jones Day

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

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The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

Hogan Lovells

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

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On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

Goodwin

US FDA Delays Approval of Biocon and Mylan’s Biosimilar for Trastuzumab

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As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (pegfilgrastim) and Ogivri (trastuzumab), and have filed applications for marketing authorization in the European...more

Patterson Belknap Webb & Tyler LLP

Update on Biosimilar Approvals and Pending Applications in Europe and the U.S.

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Approvals of biosimilar products in Europe continue to outpace those in the United States. 28 biosimilars are currently approved in Europe and five in the U.S. In 2017, the European Medical Agency has approved six...more

Goodwin

EC Approves Amgen’s Biosimilar Adalimumab

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Amgen announced yesterday that the European Commission (EC) has granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications, including certain adult and pediatric inflammatory diseases. ...more

Goodwin

Amgen Has Filed for EU Approval for Herceptin® (Trastuzumab) Biosimilar

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During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated that Amgen has filed for approval in the EU...more

Fish & Richardson

First Biosimilar Monoclonal Antibody in Oncology Granted EU Approval: Implications for the U.S. Market

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Recent developments in Europe may augur a new push for oncology biosimilars in the United States. On February 22, 2017, the European Commission approved Celltrion’s Truxima™ for all indications of reference rituximab...more

Patterson Belknap Webb & Tyler LLP

Biosimilars in Europe: 2016 Year in Review and What’s Ahead

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Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more

Goodwin

Biosimilars’ Adaptation in Europe – Considerations Beyond Price

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Precision for Value evaluated various considerations that factor into the level of biosimilars uptake, focusing primarily on Europe’s recent introduction of biosimilar anti-tumor necrosis factor drugs (anti-TNF drugs). ...more

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

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Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

McGuireWoods LLP

European Generics and Biosimilars – Legal Trends and More Discussed at 11th Annual Legal Affairs Forum – Part One of Two

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On March 26-27, 2015, the European Generic and Biosimilar Medicines Association (“EGA”) held its 11th Annual Legal Affairs Forum. The Forum kicked off with an introduction by Sergio Napolitano, Legal Affairs and Trade...more

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