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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Articles

Biosimilar teriparatide has been shown to be as safe and effective as its reference product for osteoporosis treatment, potentially enabling significant cost savings in Japan’s health care system while addressing persistent misconceptions about biosimilar quality. 

Biosimilar Teriparatide Matches Forteo in Safety and Fracture Risk

When compared with reference aflibercept, a biosimilar ranibizumab was a clinically effective and cost-saving alternative in a study assessing Japanese patients with different subtypes of neovascular age-related macular degeneration (nAMD).

Cost-Benefits, Efficacy of Biosimilar Ranibizumab vs Aflibercept for nAMD in Japan

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

A Banner Year for Biosimilars: The 19 FDA Approvals From 2024

Sarfaraz K. Niazi, PhD, dives into the role that biosimilar associations and organizations play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.

BioRationality: Biosimilar Associations and Stakeholders Representing Biosimilars

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Clinical

1.5 Credits / Cardiology, Neurology, Rare Diseases

Exploring Transthyretin-Mediated Amyloidosis and Its Phenotypes: A Comprehensive Approach to Patient Treatment

1.0 Credit / Gastroenterology, Immunology, Rare Diseases

Managed Care Insights on the Advances in the Eosinophilic Esophagitis Treatment Landscape

Korean drugmakers hold over 50% market share in the 6 best-selling biosimilar markets, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.

Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals

The FDA approved Bkemv (eculizumab-aeeb) as the first biosimilar to Soliris (eculizumab) for 2 rare diseases. It was also approved with interchangeability.

FDA Approves First Eculizumab Biosimilar

IQVIA’s report on the impact biosimilar competition has had on Europe’s health care space identified ongoing challenges with biosimilar access and generating savings, calling for more policies focusing on fostering a sustainable market for years to come.

IQVIA Report Flags Challenges With Biosimilar Access, Savings Throughout Europe

The European Commission has granted marketing authorization to Samsung Bioepis' biosimilar referencing Soliris (eculizumab). The product, dubbed Epysqli, is the first hematology biosimilar from Samsung Bioepis to be approved in the European Union.

Samsung Bioepis' Eculizumab Biosimilar Approved in Europe

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. 

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

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