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Pharmaceutical Industry › Johnson & Johnson › FDA Approval

Goodwin

Bio-Thera Announces Acceptance of BLA for BAT2506 Referencing Johnson & Johnson’s SIMPONI® (Golimumab)

Goodwin on

On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing...more

Venable LLP

Bio-Thera Submits aBLA for Simponi® (golimumab) Biosimilar BAT2506

Venable LLP on

On July 16, 2025, Bio-Thera Solutions and Accord announced the FDA acceptance of their aBLA for BAT2506, a proposed biosimilar of Janssen / Johnson & Johnson’s Simponi® (golimumab).  ...more

Knobbe Martens

Johnson & Johnson Study Shows Promise for the Treatment and Potential Cure of Multiple Myeloma

Knobbe Martens on

On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated with CARVYKTI®...more

Venable LLP

March Stelara® Biosimilar Launches: Fresenius Kabi’s Otulfi® and Celltrion’s Steqeyma™

Venable LLP on

On March 3, 2025, Fresenius Kabi and Formycon announced the launch of Otulfi™ (ustekinumab-aauz), a provisionally interchangeable biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab), subject to the...more

Venable LLP

aBLA Updates: Stelara® Biosimilar Steqeyma™ (ustekinumab-stba) FDA-Approval; Lucentis® Biosimilar Xlucane™ (ranibizumab) aBLA...

Venable LLP on

On December 17, 2024, the FDA approved Celltrion’s Steqeyma™ (CT-P43) (ustekinumab-stba) as the seventh biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab).  Celltrion previously reached a settlement agreement...more

Parker Poe Adams & Bernstein LLP

Permanent Approval of the Pfizer COVID-19 Vaccine May Prompt Employers to Mandate Vaccinations

Parker Poe Adams & Bernstein LLP on

On Monday, the Food and Drug Administration gave permanent approval to Pfizer’s COVID-19 vaccine. Similar approval of the Moderna vaccine may be forthcoming, with eventual approval of the Johnson & Johnson one-shot...more

Patrick Malone & Associates P.C. | DC Injury...

$8 billion Risperdal verdict? It’s not the money, it’s the message, Big Pharma

Patrick Malone & Associates P.C. | DC Injury... on

When regular citizens get together in the civil justice system to deliberate difficult claims about complex matters, they may not get everything just right to the satisfaction of the disputing parties. But jurors’ wisdom and...more

Patterson Belknap Webb & Tyler LLP

The Travails of the First U.S. EPO Biosimilar

Patterson Belknap Webb & Tyler LLP on

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

Searcy Denney Scarola Barnhart & Shipley

Xarelto’s Approval by the FDA

Searcy Denney Scarola Barnhart & Shipley on

The controversy over Xarelto’s approval by the FDA and alleged irregularities in the conduct of the ROCKET-AF clinical trial continue to hang over the heads of Bayer and Janssen (a division of Johnson & Johnson), the...more

Foley & Lardner LLP

FDA Panel Shows Strong Support for a Remicade Biosimilar

Foley & Lardner LLP on

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

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