The Center for Biosimilars Staff

October 16, 2017

In an ongoing litigation over biosimilar adalimumab, AbbVie, maker of the blockbuster reference adalimumab (Humira), denied biosimilar developer Boehringer Ingelheim’s claims that the company has been padding its patent estate with overlapping patents in an effort to protect its drug from competition.

October 15, 2017

Who will be the first manufacturer to succeed in gaining European or United States regulatory approval for a biosimilar pegfilgrastim product?

October 12, 2017

On this World Arthritis Day, patients with inflammatory diseases have increasing treatment options as biosimilars gain regulatory approval and become more widely available for use. New clinical data also help support the efficacy and safety of these therapies.

October 11, 2017

Navigator programs, which provide outreach, education, and enrollment assistance to consumers eligible for health coverage through the Affordable Care Act marketplace and Medicaid, learned on August 31, 2017, about a 40% CMS spending cut on the program, with a wide disparity in funding cuts per state.

October 10, 2017

The FDA has issued a Complete Response Letter for Mylan and Biocon’s pegfilgrastim biosimilar, MYL-1401H, referenced on Neulasta.

October 09, 2017

A study newly published in Archives of Disease in Childhood sought to develop much-needed data specific to the treatment of pediatric inflammatory bowel disease with biosimilar infliximab, with a focus on safety and effectiveness.

October 08, 2017

An international panel of healthcare stakeholders recently released consensus recommendations for the use of biosimilars to treat rheumatologic diseases. Learn more about what the panel had to say.

October 07, 2017

After having warned that it could lose up to 94% of its staff in a relocation from its current home in London, United Kingdom, The European Medicines Agency (EMA) this week revealed its top location choices for the agency’s upcoming move.

October 06, 2017

The Federal Trade Commission (FTC) has announced a November 8 workshop that will focus on competition issues related to prescription drug marketing.

October 05, 2017

In addition to addressing the humanitarian toll that Hurricane Maria has taken on the residents of Puerto Rico, an additional, long-term challenge in coping with the storm’s aftermath is the potential for drug shortages.