Kelly Davio

February 13, 2018

Researchers found that the biosimilar offered only limited efficacy when used for induction of remission in patients with moderate to severe ulcerative colitis that was refractory to treatment with steroids.

February 12, 2018

On Friday, the White House’s Council of Economic Advisors (CEA), an agency within the Executive Office of the President, released a white paper titled “Reforming Biopharmaceutical Pricing at Home and Abroad.”

February 09, 2018

With a new budget bill having been signed by President Trump, the second government shutdown of 2018 is now over. The Bipartisan Budget Act of 2018 contains several provisions of interest to biosimilars stakeholders.

February 09, 2018

The Federal Circuit on Monday affirmed a previous district court dismissal of drug maker AbbVie’s suit against MedImmune Limited over US Patent 6,248,516 (“the ’516 patent”).

February 08, 2018

The American College of Rheumatology (ACR)'s previous position on biosimilars was one of caution during the initial development, evaluation, and approval of these drugs, but, writes the organization, “Now that biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use, and as the [United States] is on the verge of a similar transition, the ACR is poised to reconsider its position.”

February 07, 2018

YL Biologics, a partnership forged between Lupin Pharmaceuticals and Yoshindo Inc to develop and market biosimilar therapies, has announced the successful completion of a global, phase 3 clinical trial of its proposed etanercept biosimilar, YLB113.

February 06, 2018

Because serum tumor necrosis factor (TNF) is high in patients with Kawasaki disease (KD), infliximab, an anti-TNF agent, has been proposed as a potential treatment for refractory KD, but few randomized trials have been conducted to demonstrate the efficacy and safety of using infliximab in this setting.

February 05, 2018

Former Representative Henry Waxman told The Center for Biosimilars® in an email that the CREATES Act “…tackles one of the numerous problems driving high drug prices—drug manufacturers’ use of anti-competitive tactics to block access to generic drugs.

February 05, 2018

Biosimilars have begun to erode sales of Roche’s innovator rituximab (MabThera in Europe, Rituxan in the United States), according to the drug maker’s 2017 annual report.

February 02, 2018

Patients for Biologics Safety and Access, a coalition of patient advocacy organizations, called on the US Senate Committee on Health, Education, Labor and Pensions and the House Committee on Energy and Commerce to convene oversight hearings on biosimilar medicines.