Generic Drugs, Food and Drug Administration (FDA), Commercial Marketing

Biosimilars in 2020: What’s Ahead

Kramer Levin Naftalis & Frankel LLP on 1/10/2020

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

Basics of the BPCIA

Womble Bond Dickinson on 11/21/2016

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

Can FDA Implement The BPCIA As The CAFC Suggested?

Foley & Lardner LLP on 7/22/2016

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling

Patterson Belknap Webb & Tyler LLP on 7/13/2016

Amgen and Hospira have fired off dueling letters to the court in their litigation over Amgen’s Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009...more

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

Fenwick & West LLP on 7/13/2016

Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a biosimilar applicant...more

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

Sterne, Kessler, Goldstein & Fox P.L.L.C. on 7/8/2016

The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more

Federal Circuit Invites FDA's Early Licensure of Biosimilars to Encourage Pre-Launch Resolution of Patent Disputes

Foley Hoag LLP on 7/7/2016

In its July 5, 2016 decision in Amgen v. Apotex, the Federal Circuit interpreted the Biologics Price Competition and Innovation Act (BPCIA) for the second time. The Court reiterated that the BPCIA requires a biosimilar...more

Federal Circuit Rules on Biosimilar Notice Requirement

Knobbe Martens on 7/7/2016

Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more

Fed Circuit’s “Amgen v. Apotex” Decision: Clarification of a BPCIA Riddle (Unless, of course, the Supreme Court Steps In)

Mintz - Intellectual Property Viewpoints on 7/6/2016

On July 5, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Apotex Inc., Fed. Cir. Case No....more

Generic Drugs › Food and Drug Administration (FDA) › Commercial Marketing

Biosimilars in 2020: What’s Ahead

Basics of the BPCIA

Can FDA Implement The BPCIA As The CAFC Suggested?

Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

Federal Circuit Backs Amgen on Key Provision of Biosimilars Statute

Federal Circuit Invites FDA's Early Licensure of Biosimilars to Encourage Pre-Launch Resolution of Patent Disputes

Federal Circuit Rules on Biosimilar Notice Requirement

Fed Circuit’s “Amgen v. Apotex” Decision: Clarification of a BPCIA Riddle (Unless, of course, the Supreme Court Steps In)

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

Standing Alone – The Current Status of the BPCIA’s Notice of Commercial Marketing

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

Federal Circuit Delays Sandoz Biosimilar Launch

Generic Drugs › Food and Drug Administration (FDA) › Commercial Marketing

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