The Center for Biosimilars Staff

April 22, 2019

National guidelines and reimbursement rules are likely to be key drivers of disparities; in some countries, biologics are not reimbursed at all, while in others, patients may need to have high disease activity levels, or may need to fail numerous small-molecule drugs before gaining access to biologics. Differences in cost-effectiveness thresholds used in Health Technology Assessments may also be a factor.

April 21, 2019

After treatment withdrawal, 58.3% of patients with ankylosing spondylitis (AS) had relapsed. Half of the relapses appeared within 6 months.

April 18, 2019

Fuji Pharma will market Alvotech’s biosimilar ustekinumab in Japan, the companies announced this month.

April 16, 2019

The Community Oncology Alliance (COA) recently released a position statement about biosimilars, saying it will work with stakeholders to support the acceptance of biosimilars as well as work to close knowledge gaps, given the burdensome cost of cancer care.

April 16, 2019

The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) first published their guidelines on erythropoiesis-stimulating agents (ESAs) in cancer care in 2002, with updates in 2007 and 2010, and the new update is the first to address biosimilar epoetin alfa.

April 13, 2019

Genor Biopharma, a China-based drug developer that is engaged in development of a number of biosimilars, has completed a phase 1 study of a proposed infliximab biosimilar, GB242, referencing Remicade.

April 12, 2019

While the United States awaits the launch of its first biosimilar rituximab, other regulatory jurisdictions have biosimilars referencing Rituxan already available on the market. One such product, available in South America, the Middle East, and Africa, is RTXM83, developed by drug maker mAbxience.

April 11, 2019

Russian drug manufacturer Generium Pharmaceutical, which specializes in orphan drugs, announced yesterday that it has received Russian marketing approval for its biosimilar eculizumab, referencing Soliris, the most expensive orphan drug in Russia.

April 11, 2019

Between reference infliximab and biosimilar infliximab CT-P13 (Inflectra, Remsima), different recommendations exist for the clinical solutions. Recently, a research article, published in BioDrugs, assessed and compared the stability of the solutions prepared from the originator and the biosimilar using a set of characterization methods in line with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use recommendations.

April 10, 2019

During this week’s 21st Congress of the Asia Pacific League of Associations for Rheumatology and Australian Rheumatology Association, held April 8-11 in Brisbane, Australia, multiple groups of researchers are reporting on the real-world use of biosimilars in rheumatology. According to these research teams, biosimilars are proving to be effective in the real-world clinical setting.