Kelly Davio

January 23, 2018

Remicade earned approximately $1.47 billion globally in the fourth quarter of 2017, compared with $1.62 billion in the same period in 2016. The overall drop in Remicade sales included an 8.5% slide in US sales, a 5.5% increase in sales of US exports, and an 18.7% decline in international sales.

January 22, 2018

Some data that physicians would like to see demonstrated in bioequivalence studies may not be feasible in clinical trials due to the number of patients who would have to be enrolled in the studies.

January 22, 2018

The Brazilian Society of Clinical Oncology has released its official position on the use of biosimilars in oncology. Thus far, only 2 oncology biosimilars (filgrastim and trastuzumab) have been approved for use in Brazil, though the number of applications filed with the National Health Surveillance Agency is expected to grow steadily in the coming years.

January 19, 2018

Amgen and Allergan announced on Thursday that the European Commission has granted a marketing authorization to Mvasi, a biosimilar bevacizumab referencing Avastin, for the treatment of certain cancers.

January 18, 2018

Biosimilar developer Sandoz announced today that it has entered into a global partnership with India-based Biocon to develop, manufacture, and commercialize multiple biosimilars targeting immunology and oncology indications.

January 17, 2018

A newly published retrospective study found that patients who received a combination therapy with infliximab and azathioprine early on had significantly increased linear growth compared to patients whose therapy was stepped up.

January 17, 2018

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced yesterday that it will not make any sudden changes to the nation’s regulatory framework following the country’s exit from the European Union.

January 16, 2018

Sandoz, a division of Novartis, announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed adalimumab biosimilar (referencing AbbVie’s Humira).

January 15, 2018

Rituximab is approved for use in hematological malignancies and in rheumatoid arthritis (RA), but is also used off-label in the treatment of antibody-dependent auto-immunological diseases. In off-label indications, alternative dosing schedules are sometimes used, though no dose-finding trials are available to help guide dosing in such diseases.

January 12, 2018

On Thursday, the FDA announced that it is taking new steps in 2018 to make the development and approval of biosimilars more efficient.