The Center for Biosimilars Staff

June 27, 2017

Today, Sanofi and Regeneron announced that the European Commission has granted marketing authorization for the companies’ sarilumab (Kevzara), which is approved to treat severely active rheumatoid arthritis, and which outperformed Humira in a phase 3 trial.

June 26, 2017

Earlier this month, Biocad obtained a marketing authorization for its rituximab biosimilar in Bolivia and Honduras. The product, USMAL, will be available to patients within months. Yet the Russian firm sees roadblocks ahead for US market entry.

June 25, 2017

The Biologics Prescribers Collaborative released its comment letter to the FDA on the agency’s Considerations in Demonstrating Interchangeability, and made 5 key requests.

June 23, 2017

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion Biogen’s adalimumab biosimilar, SB5 (also known as Imraldi), referencing Humira.

June 22, 2017

The Senate today revealed its long-anticipated healthcare reform bill, The Better Care Reconciliation Act of 2017. Like the House bill, the Senate legislation leaves some features of the ACA intact, including the BPCIA.

June 21, 2017

Worldwide prescription drug sales could reach $1.06 trillion by 2022, according to a new report. This earning represents only a 6.5% compound annual growth rate, and biosimilars may well play a significant role in curbed growth.

June 20, 2017

Amgen announced Monday that the FDA has accepted its supplemental Biologics License Application for denosumab.

June 18, 2017

A viewpoint published in JAMA explains why biosimilar drugs approved in the United States for the treatment of chronic diseases may not result in expected cost savings.

June 17, 2017

A new survey of 47 healthcare C-suite executives found that drug spending has increased among healthcare leaders. That trend, the report’s authors say, will only increase in the coming years, and health system leaders will need strategies to cope with the burden.

June 15, 2017

On Wednesday, Boehringer Ingelheim announced results from a phase 3 trial of its adalimumab biosimilar candidate, BI 695501. The study’s results showed that BI 695501 and AbbVie’s branded adalimumab, Humira, have similar clinical efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis.