Kelly Davio

December 03, 2018

The Biosimilars Forum is lending its support to Pfizer’s August 2018 citizen petition to the FDA to clarify appropriate sponsor communications about biosimilars.

December 02, 2018

Patients who are candidates for hematopoietic stem cell transplantation (AHSCT) require adequate collection of stem cells, and granulocyte colony-stimulating factor agents (G-CSFs) are typically used for stem cell mobilization while plerixafor is used to increase the yield of mobilized stem cells. While the biosimilar filgrastim agent Zarxio has become a more widely used, cost-saving G-CSF option in this context, little research has been conducted on whether the use of the biosimilar rather than its reference, Neupogen, has an impact on plerixafor use in patients undergoing AHSCT.

November 30, 2018

During November 2018, biosimilar developers worldwide made tough choices about how to move forward with their products and pipelines.

November 29, 2018

JCR Pharmaceuticals announced yesterday that it has launched its biosimilar agalsidase beta product, referencing Fabrazyme, in Japan for the treatment of Fabry disease. JCR developed the drug in partnership with Amicus Therapeutics and GlaxoSmithKline.

November 29, 2018

A founding member of the Biosimilars Forum has withdrawn its membership from the organization. Amgen has confirmed to The Center for Biosimilars® that it gave up its membership in the group in September of this year.

November 29, 2018

The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs).

November 28, 2018

This month, the Court of Justice of the European Union ruled that Italy’s national health system can reimburse for the use of bevacizumab in the treatment of eye diseases, such as age-related macular degeneration, despite the fact that bevacizumab does not have a marketing authorization for this indication.

November 28, 2018

The Association of the British Pharmaceutical Industry, a trade group representing UK drug makers, announced that it has reached a voluntary deal with the UK government that involves capping the growth of sales of brand-name drugs to the National Health Service at 2% per year in exchange for faster product launches and speedier appraisals by the National Institute for Clinical Excellence (NICE).

November 27, 2018

The proposed rule would allow plans to make broader use of prior authorization and step therapy for drugs—including drugs in protected classes—that are covered under Part D.

November 26, 2018

This morning, the United Kingdom’s National Health Service (NHS) announced that it has completed negotiations over using the best-value adalimumab product, and it has arrived at a plan whereby it will save £300 million (approximately $386 million) of its current £400 million-per-year (approximately $514 million) spending on adalimumab.