The Center for Biosimilars Staff

January 25, 2018

A study published yesterday in Cancer Chemotherapy and Pharmacology reports that pharmacokinetic (PK) and pharmacodynamic (PD) data from a randomized, double-blind, phase 3 clinical study show similarity between mAbxience’s proposed rituximab biosimilar, RTXM83, and its reference, MabThera, using a population PK model approach.

January 24, 2018

Three drug developers have made recent strides forward with their biosimilars or proposed biosimilar referencing Enbrel (etanercept), with new product approvals, manufacturing developments, and growing sales.

January 20, 2018

Drug maker Alteogen has announced that it will file an Investigational New Drug (IND) application with the FDA for its proposed biosimilar aflibercept (ALT-L9), an anti–vascular endothelial growth factor therapy referencing Regeneron’s Eylea, during 2018.

January 19, 2018

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 15, 2018.

January 19, 2018

On January 11, Celltrion and its partner Teva filed 2 new lawsuits against Genentech in a California district court.

January 16, 2018

Three European nations are amending their policies in order to create better conditions for biosimilar uptake and the cost savings that biosimilars provide to health systems.

January 15, 2018

MedPAC called for changes to Medicare Part D to remove the financial disincentives that block the use of lower-cost biosimilar therapies.

January 14, 2018

At this week’s 36th Annual J.P. Morgan Healthcare Conference, numerous biosimilar developers and reference product sponsors outlined their plans for the future. Our infographic provide 9 key takeaways.

January 13, 2018

Innovator drug developer Genentech, maker of the biologic therapies Avastin (bevacizumab) and Rituxan (rituximab), faces challenges from biosimilar developers in the United States and abroad. This week saw developments in cases concerning both molecules in US and Japanese courts of law.

January 11, 2018

On the third day of the 36th Annual J.P. Morgan Healthcare Conference, Samsung Biologics, which forms Samsung Bioepis together with its partner Biogen, explained that its success is driven by short development timelines for its biosimilar products. Meanwhile, AbbVie, maker of the blockbuster Humira, featured its arsenal of products that could help insulate the drug developer from biosimilar adalimumab competition.