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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Goodwin

Alexion and Samsung Settle Eculizumab BPCIA Case

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​​​​​​​On August 30, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) and Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) settled their BPCIA dispute related to...more

Goodwin

FTC Comment on FDA Draft Guidance on Interchangeability

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We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...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

FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU

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​​​​​​​On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have...more

Fish & Richardson

Biologics and Biosimilars Landscape: IP, Policy, and Market Developments

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In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more

Goodwin

Fresenius Kabi and Formycon Reach Settlement Agreement for Ustekinumab Biosimilar Candidate in Europe and Canada

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On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the...more

Smart & Biggar

Update on biosimilars in Canada – March 2024

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In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, and market access) since our March 2023 update....more

Goodwin

Updates on Aflibercept BPCIA Litigation - March 2024

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As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a motion seeking to establish a multi-district litigation (“MDL”) encompassing the aflibercept BPCIA cases it has filed in...more

Venable LLP

The PTAB Finds Claims of Two EYLEA® Patents Unpatentable and Regeneron Files its Sixth Complaint Against a Proposed EYLEA®...

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The new year has brought a wave of activity for EYLEA® (aflibercept) biosimilars. Following up on our previous report (EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates, December 31, 2023), in...more

Goodwin

Biosimilar Regulatory Updates - February 2024

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On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. CT-P47 references Genentech’s ACTEMRA, an interleukin 6 receptor...more

Goodwin

Year in Review: Top Legal Developments of 2023

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​​​​​​​As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more

Procopio, Cory, Hargreaves & Savitch LLP

USPTO Provides Guidance in Light of Amgen v. Sanofi

Procopio, Cory, Hargreaves & Savitch LLP on

The U.S. Supreme Court’s May 2023 decision in Amgen, Inc. v. Sanofi (Amgen) sent shock waves through the patent world, particularly in the chemical and biotech segments, due to its invalidation of Amgen patents based on a...more

Goodwin

Breaking: Judgment in Regeneron v. Mylan (aflibercept) BPCIA Case Finding Some Claims of Asserted Patents Valid and Infringed

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As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. The...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Another Interchangeable Biosimilar

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Earlier this year, the U.S. Food and Drug Administration announced approval of Amgen's Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Janssen Biotech's Stelara (ustekinumab).  The drug was approved for...more

Goodwin

Biosimilar Deals Updates: Biocon, AstraZeneca

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As an update to our previous report, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced the successful completion of the transition of the acquired biosimilars business in approximately 120 countries, a year ahead...more

Goodwin

Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

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In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents....more

Venable LLP

Stelara® Biosimilar Updates: IPR Petition Challenging U.S. Patent No. 10,961,307 Filed and SB17 Settlement and Launch Date...

Venable LLP on

On November 22, 2023, Biocon Biologics Inc. (“Biocon”) submitted a Petition for Inter Partes Review of claims 1-34 of U.S. Patent No. 10,961,307 (“the ’307 patent”), assigned to Janssen Biotech, Inc. (“Janssen”), requesting...more

Goodwin

Regeneron Sues Formycon AG for Proposed Biosimilar of EYLEA in West Virginia District Court

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​​​​​​​Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 29, 2023, against Formycon AG (“Formycon”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement of 39...more

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

New BPCIA Case Filed: Genentech and Biogen Want to Stop Dr. Reddy’s Rituximab Biosimilar from Entering the U.S. Market

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

On November 17, 2023, Genentech, Hoffman-La Roche, and Biogen (collectively “plaintiffs”) filed a complaint in the federal district court for the District of New Jersey against Dr. Reddy’s Laboratories and Fresenius Kabi...more

Goodwin

Regeneron Sues Samsung Bioepis for Proposed Biosimilar of EYLEA in West Virginia District Court

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​​​​​​​Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 22 against Samsung Bioepis Co., Ltd. (“Bioepis”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement...more

Goodwin

Genentech and Biogen File Joint Stipulation of Dismissal in BPCIA Litigation Regarding Tocilizumab

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​​​​​​​As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions,...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

American Conference Institute (ACI)

[Event] 14th Summit on Biosimilars & Innovator Biologics - June 27th - 28th, Boston, MA

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Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more

Foley & Lardner LLP

The BioPharma Patent Cliff: 2023 and Beyond

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A “patent cliff” refers to the end of IP protection for a drug that has enjoyed market exclusivity since its launch. Various types of regulatory exclusivity can occasionally lengthen the protection for drugs, but generally...more

Venable LLP

The State of Biosimilars in 2023

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It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market. While there have been challenges over this time, the U.S. biosimilar...more

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