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License Agreements Pharmaceutical Industry

Cooley LLP

Key Trends and Considerations in Cross-Border Life Sciences Partnering-Licensing and NewCo Transactions Between Chinese and...

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Over the past decade, the landscape of cross-border partnering in the life sciences sector has undergone a dramatic transformation, particularly in transactions between Chinese biotech companies and their US and European...more

Goodwin

Bio-Thera Announces Acceptance of BLA for BAT2506 Referencing Johnson & Johnson’s SIMPONI® (Golimumab)

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On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more

Venable LLP

Bio-Thera Submits aBLA for Simponi® (golimumab) Biosimilar BAT2506

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On July 16, 2025, Bio-Thera Solutions and Accord announced the FDA acceptance of their aBLA for BAT2506, a proposed biosimilar of Janssen / Johnson & Johnson’s Simponi® (golimumab).  ...more

Goodwin

Lupin and Zentiva Reach Agreement to Commercialize Certolizumab Pegol Biosimilar

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On July 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin’s biosimilar of Certolizumab Pegol across multiple global markets. ...more

Hudnell Law Group

Federal Circuit Enforces Gatekeeping Role in Patent Damages Testimony

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On May 21, 2025, the United States Court of Appeals for the Federal Circuit, sitting en banc, reversed a $20 million damages award against Google LLC in a patent infringement dispute with EcoFactor, Inc. EcoFactor, Inc. v....more

Goodwin

Commercialization of Ustekinumab and Golimumab Biosimilars

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This Monday, Bio-Thera Solutions and Dr. Reddy’s Laboratories SA announced that they had entered into commercialization and licensing agreements for proposed ustekinumab and golimumab biosimilars in Southeast Asia....more

Goodwin

FDA Accepts U.S. Biologics License Application for AVT06, Alvotech and Teva’s Proposed Aflibercept Biosimilar

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On February 18, 2025, Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to...more

Goodwin

Teva Announces New Biosimilar Deals

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​​​​​​​On January 10, 2025, Teva Pharmaceutical Industries Ltd. and Samsung Bioepis Co., Ltd. announced that they entered into a licensing agreement to commercialize EPYSQLI® (eculizumab-aagh), Samsung’s biosimilar of...more

Goodwin

Recent Ustekinumab and Denosumab Biosimilars Deals

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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

Goodwin

Bio-Thera and Gedeon Richter Reach Exclusive Commercialization Agreement for Ustekinumab Biosimilar

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On October 9, 2024, Bio-Thera Solutions and Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to STELARA (ustekinumab). ...more

Jones Day

NIH Seeks Comments on Patient Access Plan Requirements in Patent License Agreements

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The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more

ArentFox Schiff

Breaking: Third Circuit Declares Mallinckrodt’s Future Royalty Payment Obligations Dischargeable – Caution, Warning, and Options

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On April 25, the US Court of Appeals for the Third Circuit issued its precedential opinion in Mallinckrodt v. Sanofi-Aventis, Case No. 23-1111, reminding everyone that “creditors take on risks” when it ruled that the debtor...more

Goodwin

Janssen and Samsung Bioepis Settle STELARA (Ustekinumab) Litigation

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Samsung Bioepis recently reported that it has signed a settlement and license agreement with Johnson & Johnson (“J&J”) in the United States relating to SB17, Samsung Bioepis’s ustekinumab biosimilar to J&J’s STELARA®. If SB17...more

Goodwin

Formycon Enjoined From Manufacturing FYB202 Biosimilar of STELARA in Germany

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​​​​​​​As previously reported, in February 2023, Formycon and Fresenius Kabi entered into a global license agreement to commercialize FYB202, a ustekinumab biosimilar of Janssen’s STELARA, in key global markets after...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - September 2023

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This marks the first issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will...more

Goodwin

Genentech Files Lawsuits Against Biogen and Millennium for Past Royalties on the Cabilly Patents

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This week, Genentech filed separate lawsuits against Biogen and Millennium, alleging breach of a license agreement to the Cabilly patents (U.S. Patent No. 6,331,415 and 7,923,221)....more

Goodwin

Alteogen and Sandoz Enter a Biosimilars Agreement Relating to Subcutaneous Products

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​​​​​​​Alteogen Inc. announced that it entered an exclusive license agreement with Sandoz AG pursuant to which Sandoz will have world-wide rights to use Alteogen’s ALT-B4 hyaluronidase, derived using Hybrozyme™ Technology, to...more

Goodwin

Biosimilars Licensing Agreement Updates

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Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market. Pursuant to...more

Goodwin

Organon and Henlius Entered into a Global License Agreement for Henlius’s PERJETA® (Pertuzumab) and PROLIA®/XGEVA® (Denosumab)

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Organon announced yesterday that it has entered into an agreement with Henlius, whereby Organon will license commercialization rights for biosimilar candidates referencing PERJETA® (pertuzumab) and PROLIA®/XGEVA®...more

Goodwin

Deal Watch: Henlius Licenses Rituximab and Trastuzumab Products to Abbott in Brazil

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Earlier this week, Shanghai Henlius Biotech, Inc. announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay S.R.L. for the commercialization of HANLIKANG (rituximab) and HANQUYOU...more

Knobbe Martens

Pfizer Australia Announces Deal to Acquire ResApp Health

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ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of...more

Goodwin

Biocon Biologics Ltd. To Acquire Viatris Biosimilars Portfolio

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On Monday, Biocon Biologics Limited (Biocon) announced that it will acquire Viatris’ rights in biosimilars assets for up to $3.3 billion. Viatris and Biocon previously partnered to bring SEMGLEE to market in the U.S. ...more

Goodwin

Biogen and Xbrane Enter into Worldwide Commercialization and License Agreement for Certolizumab Pegol Biosimilar

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On February 7, 2022, Biogen Inc. and Xbrane Biopharma AB announced that they had entered into a commercialization and license agreement related to Xcimzane, a certolizumab pegol biosimilar referencing CIMZIA. Under the...more

Goodwin

Alvotech and BiosanaPharma Enter Exclusive Global Licensing Agreement for AVT23

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Alvotech Holdings S.A. (“Alvotech”) announced that it has entered into an exclusive global licensing agreement with BiosanaPharma to co-develop AVT23 (also called BP001), a proposed biosimilar to Xolair® (omalizumab). Xolair®...more

Goodwin

Bio-Thera Solutions and Hikma Pharmaceuticals Enters Into Ustekinumab Biosimilar Agreement

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Last week, Bio-Thera Solutions and Hikma Pharmaceuticals announced they have entered into an exclusive commercialization and license agreement to commercialize the proposed ustekinumab biosimilar product, BAT2206. According...more

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