Rheumatology

Biosimilars Check-in: Approval in Saudi Arabia, Launch in Republic of Korea, Dr. Reddy’s Completes Study

January 26th 2023

By Skylar Jeremias

Saudi Arabia approved an adalimumab biosimilar, a denosumab biosimilar entered the market in the Republic of Korea, and Dr. Reddy’s Laboratories announced the completion of a phase 3 study for its rituximab biosimilar.

Global Use of Medicines Report Predicts Biosimilars Will Save $290 Billion by 2027

January 25th 2023

By Skylar Jeremias

Article

IQVIA’s Global Use of Medicines Report for 2023 has revealed increased uptake of biosimilars around the world and predicted that biosimilars could generate nearly $300 billion in savings by 2027.

Eye on Pharma: New Partnerships; Samsung Adalimumab Updates; Phase 3 Ustekinumab Results

January 22nd 2023

By Skylar Jeremias

Article

Alteogen and Alvotech announce updates for their respective license partnerships; Samsung Bioepis speeds up interchangeability study for its adalimumab biosimilar; Dong-A ST shares positive phase 3 results for its ustekinumab biosimilar.

China's NMPA Approves Tocilizumab Biosimilar

January 16th 2023

By Skylar Jeremias

Article

The China National Medical Products Administration (NMPA) approved Bio-Thera Solutions’ tocilizumab biosimilar (BAT1806) referencing Actemra for the treatment of several rheumatic conditions.

Case Study: Treatment With Adalimumab Biosimilar Resolved Pediatric Scalp, Nail Psoriasis

January 14th 2023

By Deana Ferreri, PhD

Article

A case study outlined a pediatric case of scalp and nail psoriasis, which was successfully treated with an adalimumab biosimilar and monitored with in vivo reflectance confocal microscopy.

Phase 1 Trial for Alvotech Golimumab Biosimilar Begins

January 11th 2023

By Skylar Jeremias

Article

Alvotech announced that a phase 1 pharmacokinetic study for its golimumab biosimilar referencing Simponi has commenced.

Study: Does Adalimumab Lose Effectiveness After Switching to a Biosimilar?

January 7th 2023

By Skylar Jeremias

Article

The authors of an retrospective real-world study of patients with hidradenitis suppurativa treated with adalimumab concluded that switching patients between adalimumab products risked a greater likelihood of loss of effectiveness.

FDA Accepts BLA for Alvotech Ustekinumab Biosimilar

January 6th 2023

By Skylar Jeremias

Article

Alvotech, an Iceland-based company, announced that the FDA accepted its biologics license application (BLA) for its proposed ustekinumab biosimilar referencing Stelara. The company said it expects the FDA’s decision in the second half of 2023.

Celltrion Submits BLA for Infliximab Biobetter

January 5th 2023

By Skylar Jeremias

Article

Celltrion Healthcare submitted a biologics license application (BLA) to the FDA for its biobetter of its infliximab biosimilar allowing for subcutaneous administration (Remsima SC).

Canada Approves High-Concentration Humira Biosimilar

January 3rd 2023

By Skylar Jeremias

Article

Health Canada has approved the high-concentration version of Samsung Bioepis and Organon’s Hadlima, a citrate-free adalimumab biosimilar referencing Humira.