Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On May 28, 2024, the FDA approved Amgen’s BKEMV (eculizumab-aeeb), the first approved biosimilar of Alexion’s SOLIRIS (eculizumab). BKEMV was approved by the FDA as a 300 mg/30 mL (10 mg/mL) injection, for intravenous...more
On May 21, Alvotech announced that it had entered into a license and supply agreement with Dr. Reddy’s Laboratories SA for the commercialization of AVT03, a proposed denosumab biosimilar. Denosumab, sold by Amgen under the...more
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
On June 21, 2021, the Federal Circuit denied Amgen’s petition for en banc review of the court’s February 2021 decision in Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al., 987 F.3d 1080 (Fed. Cir. 2021), which found that...more
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order...more
Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011, and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal...more
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
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
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
Today, the FDA approved Amgen’s AVSOLA (infliximab-axxq), a biosimilar to Janssen’s REMICADE. AVSOLA has the same approved indications label as its reference product....more
Sandoz, a division of Novartis, announced on Tuesday that the FDA has accepted for review its BLA under the 351(k) pathway for a biosimilar candidate to AbbVie’s Humira (adalimumab). According to the press release, adalimumab...more
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more
Pfizer’s proposed biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa) is poised to be the first erythropoietin (EPO) biosimilar in the U.S. FDA staff recommended approval of Pfizer’s product as a...more
On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a...more
Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more
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
On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) unanimously ruled in Amgen v. Apotex that biosimilar makers must provide brand-name rivals with a 180-day notice only after receipt of...more
An FDA advisory panel unanimously voted to recommend approval of Amgen’s ABP501 biosimilar of AbbVie’s Humira (adalimumab) on July 12, 2016. Likewise, an FDA advisory panel is scheduled to consider approval of Sandoz’s...more
In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more
The Federal Circuit's July 5, 2016 opinion in Amgen v. Apotex is already being picked up and analyzed in other BPCIA litigation: in Amgen v. Hospira, Hospira has submitted the Federal Circuit’s opinion to the District Court...more
As we posted on July 5, 2016, the Federal Circuit has issued its decision in Amgen v. Apotex, affirming the district court’s (S.D. Fla, J. Cohn) order preliminarily enjoining Apotex from launching its biosimilar version of...more
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
We previously reported that the FDA approved Celltrion’s Inflectra®, a biosimilar to Janssen’s Remicade® (infliximab) on April 5, 2016. A year prior to the approval, Janssen filed a motion for summary judgment and...more
The Food and Drug Administration’s (FDAs) Arthritis Advisory Committee gave a thumbs up to a biosimilar copy of Johnson & Johnson’s Remicade product, an inflammation blocker used in the treatment of rheumatoid arthritis, on...more