Rheumatology

Phase 3 Study Underway for Proposed Etanercept Biosimilar, SCB-808

January 2nd 2020

By Kelly Davio

China-based Clover Biopharmaceuticals announced this week that it has dosed the first patient in a phase 3 clinical study of SCB-808, a proposed etanercept biosimilar referencing Enbrel.

Risk of New IBD Rises for Patients Treated With Etanercept

January 1st 2020

By Kelly Davio

While anti–tumor necrosis factor (anti-TNF) drugs are effective at treating a range of inflammatory diseases, some limited data suggest that they may, paradoxically, result in a higher risk of developing other de novo inflammatory conditions.

Elaine Husni, MD, MPH: Biosimilars and Cost Savings for Patients

December 31st 2019

Elaine Husni, MD, MPH, vice chair and director of the Arthritis and Musculoskeletal Center in the Orthopedic and Rheumatologic Institute at the Cleveland Clinic, discusses whether biosimilars are generating cost savings for patients with inflammatory diseases.

Study Identifies Factors Linked With Complete Remission in Pemphigus Vulgaris After Rituximab Therapy

December 26th 2019

By Kelly Davio

Using the same dosing as treatment for lymphoma and older age were linked with higher odds of complete remission off therapy.

Registry Reveals That Many US Patients With RA Are Not Treated to Target

December 24th 2019

By The Center for Biosimilars Staff

Study findings in patients with rheumatoid arthritis (RA), write the authors, suggest “that potentially more aggressive treatment is needed across the entire population of patients with RA."

Canadian Organizations Gather Stakeholders to Stimulate Biosimilar Acceptance

December 18th 2019

By The Center for Biosimilars Staff

The pan-Canadian Pharmaceutical Alliance engaged the Canadian Agency for Drugs and Technologies in Health to lead a multiphase stakeholder consultation process to encourage biosimilar uptake.

Lupin's Proposed Etanercept Biosimilar Shows Similarity to Enbrel, Has Lower Immunogenicity

December 16th 2019

By Kelly Davio

In May of 2018, drug maker Lupin announced that the European Medicines Agency would review its application for YLB113, a proposed etanercept biosimilar referencing Enbrel. This week, results of a phase 3 study of the biosimilar in patients with rheumatoid arthritis (RA) revealed the similarity of the product with its reference, and also demonstrated that the product has lower immunogenicity than the reference drug.

Slower Price Growth, Use of Generics Balance Higher Spending on Cancer, Autoimmune Drugs

December 10th 2019

By Allison Inserro

Increased spending on new oncology and autoimmune drugs was partially offset by a decline in price growth and the continued increase in the use of generic drugs, according to a recent report from CMS about national healthcare spending in 2018.

Biocad's Rituximab Biosimilar Shows Safety, Efficacy in NHL, RA

December 4th 2019

By The Center for Biosimilars Staff

Drug developer Biocad received approval for its rituximab biosimilar, BCD-020 (Acellbia) in Russia in 2014, and since that time, the drug has been launched in Russia and in multiple other markets around the world. While Biocad has not specified whether it plans to pursue regulatory approval for the biosimilar in the European Union, the company has announced ambitions to enter the EU market with some of its products, and researchers have published new data for the biosimilar in both oncology and rheumatology indications.

Amgen and PBM Forge Outcomes-Based Agreement for Enbrel Ahead of Biosimilar Competition

December 4th 2019

By Kelly Davio

Amgen and pharmacy benefit manager (PBM) Abarca this week announced that they have entered into an outcomes-based contract for brand-name etanercept, Enbrel.