Mary Caffrey

Phase 3 Study of Amgen Biosimilar to Eculizumab Meets Primary End Points

August 24, 2022

Eculizumab is used to treat paroxysmal nocturnal hemoglobinuria (PNH), a rare bone marrow disorder in which expansion of certain hematopoietic cells that lack a key protein cause the destruction of red blood cells, or hemolysis.

Prospective Study Finds Adalimumab Biosimilars Effective in IBD, but Fall Short of Infliximab Product

August 10, 2022

Study authors found the pair of biosimilars performed as well as others that have been evaluated in inflammatory bowel disease (IBD), but concluded that the adalimumab biosimilars were less effective in IBD than an infliximab biosimilar previously studied.

Alvotech to Launch Pharmacokinetics Study for Denosumab Biosimilar

July 20, 2022

The biosimilar candidate would reference Prolia, used in the treatment of osteoporosis in postmenopausal women and to treat bone loss in adult men and women who are at increased risk of fracture. It is also planned as a biosimilar for Xgeva, which is indicated to prevent skeletal fractures in patients with cancer.

Prior Authorization Panel Yields Insights Into Role of PBMs in Biosimilar Uptake

March 09, 2022

At a session at the Association of Community Cancer Centers’ 2022 Annual Meeting & Cancer Center Business Summit, panelists suggested that the quest for rebates by pharmacy benefit managers (PBMs) prevents uptake on some biosimilars—and could soon bleed over into biosimilar formulary placement.

Biosimilars CEOs: Opportunities Abound, but Regulatory, “Branding” Hurdles Remain

February 24, 2022

There remains risk in the US market due to regulatory and legal hurdles—not to mention a combative political environment, according to executives who gathered last week during the “CEOs Unplugged” session at Access! 2022, held by the Association for Accessible Medicines (AAM) in Orlando.