News & Analysis as of

Prescription Drugs › BPCIA › Amgen

Goodwin

Denosumab Updates: Wyost and Jubbonti Launch as First Denosumab Biosimilars in the U.S.

Goodwin on

On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. ...more

Venable LLP

First Biosimilar and Interchangeable of Stelara® (ustekinumab) Approved in the U.S.

Venable LLP on

On October 31, 2023, the FDA approved Amgen’s Wezlana™ (ustekinumab-auub) as the first biosimilar and interchangeable of Johnson & Johnson / Janssen’s Stelara® (ustekinumab).  In May 2023, Amgen and Janssen settled their...more

Goodwin

Year in Review: The Top-Five U.S. Biosimilar Market Developments of 2019

Goodwin on

As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order...more

Patterson Belknap Webb & Tyler LLP

Biosimilar Litigation Update

Patterson Belknap Webb & Tyler LLP on

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

K&L Gates LLP

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

K&L Gates LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP on

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

Mintz - ML Strategies

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

Mintz - ML Strategies on

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

Foley & Lardner LLP

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

Foley & Lardner LLP on

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

Polsinelli

Federal Circuit Delays Sandoz Biosimilar Launch

Polsinelli on

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Approves First US Biosimilar but Court Action Could Delay Market Entry

Sterne, Kessler, Goldstein & Fox P.L.L.C. on

On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more

K&L Gates LLP

ODAC Committee Votes to License Sandoz’s Zarxio®

K&L Gates LLP on

As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more

K&L Gates LLP

Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures

K&L Gates LLP on

Amgen, Inc. (“Amgen”) has brought the discussion of the procedure for biosimilar applications from the courts to the FDA by filing a Citizen Petition (Docket No. FDA-2014-P-1771) on October 29, 2014 (“Petition”) requesting...more

Sheppard Mullin Richter & Hampton LLP

No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Action Before Biosimilars Application Is Filed

Sheppard Mullin Richter & Hampton LLP on

The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price...more

13 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide