Kelly Davio

November 12, 2018

Early-onset inflammatory bowel disease (IBD) can have a more aggressive course than later-onset disease, making prompt treatment for children with IBD especially important. Given the high cost of biologics that treat pediatric IBD—adalimumab and infliximab—biosimilars are emerging as an important cost-saving option that can prevent the premature termination of biologic therapy for financial reasons.

November 12, 2018

As more biosimilars make their way to patients in the United States and Europe, stakeholders seek reassurance on switching to these products. A newly published systematic review sought to investigate the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders.

November 09, 2018

In its investor call on Thursday, Coherus Biosciences revealed that it will launch its biosimilar pegfilgrastim, Udenyca, at a 33% discount to the reference Neulasta.

November 08, 2018

Allergan’s dry-eye drug, Restasis, has been the subject of complex legal wrangling involving the transfer of patents that could next extend to the Supreme Court of the United States. Now, in a separate twist in the story of generic competition for the cyclosporine ophthalmic emulsion, generic developer Teva has sued the FDA in the United States district court for the District of Columbia over Teva’s status as the first filer of a generic version of the drug.

November 07, 2018

Notably, Oncobiologics revealed that it is developing the bevacizumab product as an innovator therapy, and it will not use the biosimilar pathway for eventual approval.

November 07, 2018

Momenta Pharmaceuticals announced yesterday that it has reached a settlement with Humira-maker AbbVie over a proposed biosimilar adalimumab, M923.

November 06, 2018

At the Department of Abdominal Oncology at the National Cancer Institute of Naples in Italy, an expert pharmacist was involved in evaluating the economic impact of improving the Italian registry of high-cost drugs, particularly bevacizumab, cetuximab, panitumumab, and trastuzumab.

November 05, 2018

Samsung Bioepis, maker of Imraldi, has developed an autoinjector device that aims to address some of the mobility limitations that patients with rheumatoid arthritis may have in self-administering their adalimumab with a syringe.

November 05, 2018

Sandoz announced on Friday that it will no longer pursue FDA approval for its biosimilar rituximab, GP2013.

November 02, 2018

In an interview with The Center for Biosimilars®, Imron Aly, JD, partner at Schiff Hardin LLP, explained that this long-running case to invoke sovereign immunity from inter partes review (IPR) carries important lessons for innovator product sponsors and generic and biosimilar developers as they consider IPR proceedings and the patent landscape as a whole.