Amgen Pharmaceutical Industry

News & Analysis as of

Enbrel Biosimilar in Europe and US

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Benepali, the first biosimilar of Enbrel...more

FDA Rejects Hospira’s EPO Biosimilar Application

After the FDA approved the first U.S. biosimilar, Sandoz’s Zarxio (filgrastim-sndz), earlier this year, many predicted that the floodgates would open for biosimilar products. That has not been the case. No other U.S....more

Apotex Follows the BPCIA “Patent Dance” Again

The first biosimilar makers to file regulatory applications with FDA attempted to bypass all or a subset of the patent litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Apotex, the...more

BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?

In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more

A Split Decision Remains Split; No en banc Review of Amgen v. Sandoz

On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more

FDA’s Proposal for Naming Biosimilars Pleases Some, Disappoints Others

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of...more

Apotex Follows the Pre-Suit Information Exchange Provisions of the BPCIA

In the first skirmishes between biosimilar makers and innovator companies, biosimilar makers attempted to bypass the litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) through the...more

Sandoz Launches First Biosimilar Drug in U.S.

A new chapter in the generics/innovator wars began Thursday as Sandoz, Novartis’ generics division launched its Neupogen biosimilar, Zarxio, in the U.S. at about a 15-30% discount from the price of Neupogen. While biosimilars...more

First Biosimilar Drug Now Available; Ongoing Legal Dispute Remains

The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more

Amgen and Apotex do the Biosimilar Patent Dance

Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. Although several complaints have...more

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

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

Identifying the likely beneficiaries of an emerging biosimilars market

Financial analysts have predicted that over the next five years, biosimilars will be a $10 billion market, so it is understandable why considerable attention and investment is being made in this space. However, while there is...more

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for...

On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar...more

"Don't Stop the Dance"[*] -- The Dissents-in-Part from Amgen v. Sandoz

As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more

Biosimilars, the BPCIA, and Amgen v. Sandoz: The Federal Circuit’s First Attempt To Make Sense of “A Riddle Wrapped in a Mystery...

On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more

Biosimilars Can Sit Out Patent Dance, But May Have To Wait Out Second Exclusivity Period

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more

Federal Circuit Delays Sandoz Biosimilar Launch

In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more

Federal Circuit Issues Its First Decision Interpreting BPCIA

The courts must “say what the law is,” even when that law, as Judge Lourie described the BPCIA, is “a riddle wrapped in a mystery inside an enigma.” Today, in Amgen Inc. v. Sandoz Inc., No. 2015-1499 (Fed. Cir. July 23,...more

Alert: Fractured Federal Circuit Provides Guidance on Biosimilars Patent Dance

Both Sides Come Away with Wins in Amgen v. Sandoz - Yesterday, in Amgen, Inc. v. Sandoz, Inc., the Federal Circuit construed multiple provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). ...more

BPCIA: A “Choose Your Own Adventure” Statute?

On June 3, 2015, the Federal Circuit heard oral argument on Amgen Inc.’s (“Amgen”) appeal of the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent...more

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

Federal Circuit Hears Oral Arguments in Neupogen Biosimilar Case

On June 3, 2015, the Federal Circuit heard oral arguments in Amgen v. Sandoz regarding the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). As reflected in Judge Lourie’s...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

Amgen Receives No Help from the FDA -- A Biosimilar Update

Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and...more

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