The Center for Biosimilars Staff

August 28, 2017

Coherus BioSciences today announced positive topline results for the first of 3 pharmacokinetic bioequivalence studies comparing CHS-1420, an adalimumab biosimilar candidate, and European-sourced reference Humira.

August 27, 2017

The National Academy for State Health Policy (NASHP), a non-profit, non-partisan academy of state health policymakers, reports the following successful 2017 drug pricing initiatives passed at the state level.

August 25, 2017

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of August 21, 2017.

August 25, 2017

Genentech, a member of Roche Group, has announced that the FDA has accepted its Biologics License Application and granted priority review for emicizumab, a once-weekly subcutaneous prophylaxis for adults, adolescents, and children with hemophilia A who have factor VIII inhibitors.

August 24, 2017

The United Kingdom (UK) has issued a position paper on ensuring a smooth economic transition from the European Union (EU) in relationship to the availability of goods, including pharmaceuticals.

August 24, 2017

Coherus BioSciences has announced that it plans to raise up to $150 million in a 2-tranche private placement deal with Temasek.

August 23, 2017

The White House confirmed last week that it will continue to make cost-sharing reduction (CSR) payments for the month of August. The Trump administration has been making decisions on whether to continue to fund CSRs on a monthly basis, and had previously suggested that it might soon put an end to CSRs.

August 23, 2017

A new paper, accepted for publication in Diabetes, Obesity and Metabolism, describes 2 recent studies that demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity between MK-1293, an insulin glargine follow-on being developed by Merck (who funded the studies), and the originator insulin glargine (Lantus).

August 22, 2017

Despite earlier White House statements indicating that the Trump administration would ask the FDA to generate 100% of its program funding through user fee programs, on August 18, the President signed the FDA Reauthorization Act of 2017 (FDARA) into law.

August 21, 2017

Sandoz announced today that it has launched its etanercept biosimilar (Erelzi) in Canada.