Tagged as: Janssen

BREAKING NEWS - HHS Announces the First 10 Drugs Selected for IRA Drug Price Negotiation Program

HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. They are: Eliquis (apixaban, Bristol Myers Squibb) Jardiance (empagliflozin, Boehringer Ingelheim) Xarelto (rivaroxaban, Janssen Pharms) Januvia (sitagliptin phosphate, Merck Sharp Dohme) Farxiga (dapagliflozin, AstraZeneca AB) Entresto (sacubitril;…

Read More

Formycon/Fresenius Kabi and Samsung Bioepis Settlements with J&J and Janssen Biotech regarding Ustekinumab

On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed by J&J.  In February 2023, Formycon announced its entry into a global license agreement with Fresenius…

Read More

Samsung Bioepis Files Four IPR Petitions on Alexion Eculizumab Patents and One IPR Petition on a Janssen Ustekinumab Patent

Samsung recently filed the following IPR petitions challenging all claims of four patents assigned to Alexion relating to SOLIRIS (eculizumab): IPR2023-00998, challenging claims 1-3 of U.S. Patent No. 9,718,880; IPR2023-00999, challenging claims 1-10 of U.S. Patent No. 9,725,504; IPR2023-01069, challenging claims 1-8 of U.S. Patent No. 10,590,189; and IPR2023-01070, challenging…

Read More

Alvotech and Teva Reach Ustekinumab (STELARA) Settlement with J&J

gloved hand withdraws drug solution with syringe

Alvotech and Teva Pharmaceuticals, Inc. announced that they reached a settlement and license agreement with Johnson & Johnson regarding AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab) in the United States.  “According to the settlement agreement, AVT04 (ustekinumab) can be marketed in the US, subject to regulatory approval, no later than…

Read More

Janssen and Amgen Settle STELARA (Ustekinumab) BPCIA Litigation

We previously reported on Janssen’s complaint alleging that Amgen’s filing of an aBLA for ustekinumab, a biosimilar of STELARA, infringes Janssen patents, and about Janssen seeking a preliminary injunction to block Amgen from the commercial manufacturing, sale, and offer for sale of its ustekinumab product.  Briefing for the PI motion was…

Read More

Purple Book Updates

FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance.  Pursuant to a law enacted in late 2020, a reference product sponsor must provide patent information to FDA for listing in the Purple Book once…

Read More

REMICADE Antitrust Settlement Receives Final Approval

In 2017, three indirect-purchaser antitrust class actions were filed against Johnson & Johnson and Janssen Biotech, Inc., alleging that they engaged in anticompetitive conduct relating to the sale and marketing of J&J’s REMICADE (infliximab).  The class actions were brought by employee welfare benefit plans, specifically the National Employees Health Plan,…

Read More

Janssen Files Redacted Public Version of Its Opening Brief in Support of Its Motion for Preliminary Injunction Against Amgen in BPCIA Ustekinumab Case

As we previously reported, on March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and offer for sale of ABP 654, Amgen’s ustekinumab biosimilar.  Last week, Janssen filed a public…

Read More

Janssen Seeks a Preliminary Injunction in BPCIA Ustekinumab Case Against Amgen

On March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and offer for sale of ABP 654, Amgen’s ustekinumab biosimilar.  On the same day, just prior to filing the motion,…

Read More

Janssen Files BPCIA Complaint Against Amgen Regarding Ustekinumab

On November 29, 2022, Janssen filed a BPCIA complaint in the District of Delaware against Amgen related to Amgen’s ustekinumb biosimilar ABP 654 of Janssen’s STELARA. This is Janssen’s first BPCIA case filed with respect to an ustekinumab biosimilar. Janssen alleges that its “scientists and clinicians spent decades developing STELARA…

Read More

12