Biologics Price Competition and Innovation Act of 2009

News & Analysis as of

Amgen v. Sandoz -- Federal Circuit Oral Argument

The Federal Circuit heard oral arguments in the Amgen v. Sandoz case on Wednesday, June 3, 2015. The three judges on the panel were Judge Newman, Judge Lourie, and Judge Chen. This case is on appeal from the U.S. District...more

The Federal Circuit’s First Foray into the BPCIA: “A Pulitzer Prize for Complexity”?

Yesterday, a Federal Circuit panel comprising Judges Newman, Lourie, and Chen heard oral argument in Amgen Inc. v. Sandoz Inc. (Fed. Cir. No. 2015-1499), the first ever case requiring the Appeals Court to address the meaning...more

BIO International Convention 2015 Preview - BIO and Biosimilars

The 2015 BIO International Convention begins in two weeks in Philadelphia. For the past few years, we have provided a series of previews with the goal of making the large amount of information and opportunities available at...more

Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical...more

The Remicade Biosimilar Patent Dispute

While Sandoz has grabbed the biosimilar headlines for being the first company to have a product approved under the Biologics Price Competition and Innovation Act (its product Zarxio™ (filgrastim-sndz) is a biosimilar of...more

Federal Circuit’s Sandoz v. Amgen Decision Forecloses Early Declaratory Judgment Suits by Biosimilars Applicants

On December 5, in the closely watched Sandoz v. Amgen case, the Federal Circuit held that a biosimilars applicant cannot use the Declaratory Judgment Act to challenge a reference product sponsor's patent prior to filing a...more

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

FDA Accepts First Biosimilar Application under New Approval Pathway

July 24, 2014 was a landmark day in the biotechnology industry: Sandoz (the generic arm of Novartis) announced that the U.S. Food and Drug Administration (FDA or “the Agency”) had accepted the first application for a U.S....more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval

As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal...more

Recent Ruling Clarifies Patent Litigation Timing Under Biosimilars Act

The first court decision interpreting the Biosimilars Act has arrived, with a federal district court in California finding that a biosimilar application must be filed with the FDA before patent litigation can be initiated....more

Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not

On March 22, Senators Max Baucus (D-MT) and Orrin Hatch (R-UT), the Chairman and Ranking Member, respectively, of the Senate Committee on Finance, sent a letter to Ambassador Demetrios Marantis, the Acting United States Trade...more

WLF Submits Comments on Abbott's Citizen Petition on Biosimilars

Last April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act...more

FDA Issues Draft Guidelines for Biosimilars

Last Thursday, the FDA issued the first set of long-awaited draft guidelines for the regulatory approval of follow-on biologic drug products, or "biosimilars," under the Biologics Price Competition and Innovation Act of 2009...more

Follow-on Biologics and Patent Reform: Will They Discourage Venture Capital Investment in the Biotechnology Industry?

According to a study by PricewaterhouseCoopers and the National Venture Capital Association, venture capital (VC) investing hit a five-year high in 2006, with $25.5 billion invested. Notably, the Life Sciences sector, which...more

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