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FDA Designates Intellia’s Nexiguran Ziclumeran (nex-z) as a Regenerative Medicine Advanced Therapy

On November 25, 2024, Intellia Therapeutics announced that its CRISPR-based therapy, nexiguran ziclumeran (nex-z, NTLA-2001), received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for treatment of...more

Life Sciences M&A Trends for 2023 and 2024 (Through End of Q3) in Greater China

Goodwin is presenting a two-part publication series covering life sciences trends involving license deals, M&A, and financing for Greater China’s life sciences sector. ...more

FDA Accepts BLA for Shanghai Henlius Biotech’s and Organon’s HLX14, a Denosumab Biosimilar

​​​​​​​On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). In 2022, Shanghai...more

PTAB Institutes Eight More IPRs Filed by Merck on Johns Hopkins Pembrolizumab Patents

​​​​​​​In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab. The eight patents are generally directed to methods...more

Express Scripts Sues FTC Over Report on Pharmacy Benefit Management Industry

​​​​​​​On September 17, Express Scripts, Inc. (“Express Scripts”), one of the largest pharmacy benefit managers (PBMs) in the United States, brought suit against the Federal Trade Commission (“FTC”) over its July 2024 interim...more

Update on Recent International Biosimilar Approvals - September 2024

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

FDA Issues Draft Guidance on Demonstrating Biosimilar Interchangeability

​​​​​​​Last month, the FDA issued draft guidance, which, if implemented, would remove a requirement for a switching study for demonstrating biosimilar interchangeability....more

MDL Panel Grants Transfer of Aflibercept BPCIA Case

As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against...more

Major Life Sciences Licensing Deal Trends in China in 2023

This is the first of two articles focused on 2023 life sciences deals in China. The second article, which is coming soon, looks at trends in M&A.  In 2023, there were 240 reported life sciences licensing deals in China,...more

Year in Review: Top Legal Developments of 2023

​​​​​​​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

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

​​​​​​​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

UK Authorizes World-First Gene Therapy from Vertex and CRISPR Therapeutics for Blood Disorders

​​​​​​​Earlier today, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics for their CRISPR/Cas9 gene therapy, CASGEVY...more

Meitheal Announces Exclusive Commercial Licensing Agreement for Insulin Biosimilars in the US

​​​​​​​Meitheal Pharmaceuticals, Inc. (“Meitheal”) has entered into an exclusive licensing deal with Tonghua Dongbao Pharmaceutical Co., Ltd. (“THDB”) to market three insulin biosimilars (insulin aspart, insulin lispro, and...more

Generic and Biosimilar Drugs Save $408B For America’s Patients and Healthcare System in 2022

On September 6, 2023, the Association for Accessible Medicines (AAM) released its 2023 U.S. Generic & Biosimilar Medicines Savings Report highlighting the significant economic contributions of generic and biosimilar...more

HUMIRA (adalimumab) Biosimilar Launches

​​​​​​​In the last week, seven adalimumab biosimilars referencing HUMIRA entered the U.S. market:  Boehringer Ingelheim’s CYLTEZO (adalimumab-adbm); Sandoz’s HYRIMOZ (adalimumab-adaz); Organon and Samsung Bioepis’s HADLIMA...more

Updates on Recent Foreign Approvals and Launches

​​​​​​​On May 26, 2023, the European Commission granted the marketing authorization to Samsung Bioepis for EPYSQLI, a biosimilar referencing SOLIRIS (eculizumab) developed by Alexion for the treatment of the paroxysmal...more

Alvotech and Advanz Pharma Extend Partnership to Commercialize Five Proposed Biosimilars in Europe

​​​​​​​Advanz Pharma (“Advanz”) and Alvotech announced that they entered an exclusive partnership agreement regarding supply and commercialization of five biosimilars in Europe, with Alvotech responsible for the development...more

Bristol-Myers Squibb Files Patent Infringement Complaint Against AstraZeneca Regarding Anti-PD-L1 Antibody Product

On April 25, 2023, Bristol-Myers Squibb (“BMS”) filed a complaint in the District of Delaware against AstraZeneca related to AstraZeneca’s anti-PD-L1 antibody product, IMFINZI (durvalumab), alleging willful infringement of...more

Purple Book Updates - 2023

​​​​​​​FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Pursuant to a law enacted in late...more

Coya Announces Agreement with Dr. Reddy’s Laboratories for Treatment of Neurodegenerative Diseases

On March 20, 2023, Coya Therapeutics, Inc. (“Coya”) announced a worldwide agreement with Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and...more

FDA Issues CRL for Biocon/Viatris Bevacizumab Biosimilar

​​​​​​​On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab), previously submitted by...more

Alvotech and Teva Announce Acceptance of BLA for AVT04, a Proposed Biosimilar to STELARA (ustekinumab)

On Jan 6, 2023, Alvotech and Teva announced that the FDA has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab), and stated that the companies...more

Alvotech Initiates Study of Biosimilar of J&J’s Rheumatoid Arthritis Drug SIMPONI

Alvotech announced yesterday the initiation of a pharmacokinetic study for AVT05, a biosimilar referencing Johnson & Johnson’s (“J&J”) SIMPONI and SIMPONI ARIA (golimumab).  SIMPONI is used to treat certain types of...more

Coherus Agrees to Acquire a Biosimilar EYLEA Candidate from Klinge Biopharma

On Jan 9, Coherus BioSciences, Inc. (“Coherus”) announced that it has agreed to acquire the exclusive commercialization rights to FYB203, a biosimilar referencing EYLEA (aflibercept) from Klinge Biopharma GmbH (“Klinge...more

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