News & Analysis as of

Biosimilars Prescription Drugs

Goodwin

Alteogen Seeks Approval for Aflibercept Biosimilar in Korea

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​​​​​​​On September 13, 2024, Alteogen announced that it has applied for marketing authorization in Korea for ALT-L9, an aflibercept biosimilar of EYLEA®. According to Alteogen, a 12-country Phase 3 study showed that ALT-L9...more

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

Venable LLP

Fifth EYLEA® Biosimilar FDA-Approved: Amgen’s Pavblu™ (aflibercept-ayyh)

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On August 23, 2024, the FDA approved Amgen’s Pavblu™ (aflibercept-ayyh) as the fifth biosimilar of Regeneron’s EYLEA® (aflibercept). Pavblu™ was approved with a skinny label that includes neovascular (wet) age-related macular...more

Smart & Biggar

Manitoba last province to introduce Biosimilars Initiative, while Ontario adds four drugs to its Biosimilar Policy

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Manitoba has implemented a Biosimilars Initiative effective August 1, 2024. Manitoba is the last province in Canada to implement a biosimilar policy that requires patients receiving funding under the Manitoba Pharmacare...more

Goodwin

EMA Accepts Marketing Authorization Application for Alvotech’s AVT06 (aflibercept)

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On August 15, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s biosimilar of low dose (2 mg) EYLEA (aflibercept)....more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

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Please see full Newsletter below for more information....more

Goodwin

Proposed BPCIA Reform Legislation Likely To Have Little Effect Even If Passed

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In an attempt to increase the availability of biosimilars, on July 11, 2024, the Senate passed the Affordable Prescriptions for Patients Act, which was introduced in the House on July 19, 2024. The bill sets a cap of 20...more

Venable LLP

EYLEA® Biosimilar Updates: Sandoz’s Enzeevu™ (aflibercept-abzv) FDA Approved, Regeneron Dismisses IPR Appeals

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On August 12, 2024, Sandoz announced the FDA approval of Enzeevu™ (aflibercept-abzv) as the fourth biosimilar of Regeneron’s EYLEA® (aflibercept).  Enzeevu™ was approved as provisionally interchangeable, subject to the...more

MoFo Life Sciences

Senate Unanimously Passes Bill To Limit Patent Infringement Challenges By Drug Manufacturers

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The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of...more

Goodwin

FDA Approves Sandoz’s ENVEEZU™ (aflibercept-abzv)

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​​​​​​​On August 12, 2024, Sandoz announced that the FDA has approved ENVEEZUTM (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. ENVEEZUTM is indicated for the treatment of neovascular (wet)...more

Foley & Lardner LLP

Cancer Drugs: Antibody-Drug Conjugate Litigation

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Antibody-drug conjugates (ADCs) are typically composed of a monoclonal antibody attached to a cytotoxic drug via a chemical linker. The antibody is able to identify biomarkers on and attach to cancer cells, allowing targeted...more

Woodruff Sawyer

3 Trends Reshaping Pharmacy Benefits Management

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In this blog and the webinar linked below, we offer a comprehensive analysis of three critical areas transforming the sector: GLP-1 medications, biosimilars, and PBM transparency. Our analysis covers diabetes and weight loss...more

Goodwin

EU Committee Recommends Approval of 6 New Biosimilars in July 2024 Meeting

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The Committee for Medicine Products for Human Use (“CHMP”) recommended 14 medicines for European Medicines Agency Approval (“EMA”) approval (“marketing authorization”), during its monthly meeting on July 22-25, 2024....more

Goodwin

FDA Issues Draft Guidance on Postapproval Manufacturing Changes to Biosimilar Products

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​​​​​​​On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more

Jones Day

U.S. Senate Unanimously Passes Bill Limiting Number of Patents Asserted Against Biosimilar Applicants

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The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more

Hogan Lovells

CMS Issues Updates Regarding ASP: Negative ASP, Radiopharmaceuticals, Restatements, and Skin Substitutes

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The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more

Alston & Bird

Health Care Week in Review: House Committee on Oversight and Accountability Held a Hearing on PBMs; HHS Reorganizes Technology,...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Goodwin

FDA Approves Samsung’s Eculizumab Biosimilar

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​​​​​​​Samsung Bioepis (“Samsung”) announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion’s SOLIRIS. EPYSQLI has been approved for the treatment of patients with paroxysmal...more

Goodwin

FDA Issues Draft Guidance on Demonstrating Biosimilar Interchangeability

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

Venable LLP

FDA Approves Second Soliris® (eculizumab) Interchangeable Biosimilar - Samsung Bioepis’s Epysqli® (eculizumab-aagh)

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On July 19, 2024, the FDA approved the second biosimilar of Alexion / AstraZeneca’s Soliris® (eculizumab), Samsung Bioepis’s Epysqli® (eculizumab-aagh), approximately one year after Samsung Bioepis announced the FDA...more

Cozen O'Connor

Cozen Currents: Is Harris the Answer?

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The Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - June 2024

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Venable’s BiologicsHQ Monthly Injection – June 2024...more

Polsinelli

Federal Circuit Clarifies Rules for Skinny Labeling for Generics and Biosimilar Companies

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Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more

Goodwin

FDA Approves Ustekinumab, Aflibercept, and Filgrastim Biosimilars

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On July 1, Samsung Bioepis Co., Ltd. announced that the FDA has approved PYZCHIVA (ustekinumab-ttwe), a biosimilar referencing STELARA (ustekinumab)....more

Venable LLP

FDA Approves Three Biosimilars - Ahzantive® (aflibercept-mrbb), Nypozi™ (filgrastim-txid), and Pyzchiva® (ustekinumab-ttwe)

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On June 28, 2024, the FDA approved three new biosimilars, Formycon and Klinge Biopharma’s Ahzantive® (aflibercept-mrbb), a biosimilar of Regeneron’s EYLEA® (aflibercept); Tanvex Biopharma’s Nypozi™ (filgrastim-txid), a...more

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