Kelly Davio

May 09, 2019

Yesterday, the federal circuit affirmed a district court’s decision in a patent dispute between Amgen and Sandoz.

May 08, 2019

The House of Representatives has passed a pair of bills that make changes to the FDA’s Orange Book and Purple Book, which provide information on generic drugs and biosimilars, respectively.

May 08, 2019

This March, the FDA released updated guidance on the naming of biologics, biosimilars, and interchangeable biosimilars. In the document, the FDA indicated that it no longer intends to retroactively give approved biologics 4-letter suffixes devoid of meaning, but it will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. In addition, FDA does not intend to add suffixes to the names of transition products. This week, the comment period on the updated guidance closed, and the FDA heard from a variety of stakeholders who asked the agency to change its direction.

May 07, 2019

Yesterday, the FDA approved Roche’s ado-trastuzumab emtansine (Kadcyla) for the adjuvant treatment of HER2-positive early breast cancer in patients who have residual invasive disease after neoadjuvant taxane- and trastuzumab-based therapy. The new indication could help to stave off some of the impact of biosimilar trastuzumab, which is expected to launch this year.

May 07, 2019

Despite potential benefits of biosimilar adoption in terms of both patient access and healthcare system sustainability, and despite ongoing efforts at patient and provider education on biosimilars, stakeholders may continue to have concerns about perceived risks with switching. A new review of the available literature on switching—from randomized controlled trials and real-world evidence—sought to address those concerns, and said that additional education and ongoing real-world evidence collection will be necessary to increasing stakeholder comfort with these agents.

May 06, 2019

Last week, biosimilar developer Coherus BioSciences announced that it has reached a settlement with innovator drug maker Amgen over a trade secret case that was pending in the Superior Court of California. Separately, Amgen filed a new complaint against biosimilar developer Samsung Bioepis.

May 05, 2019

During this week’s Association for Research in Vision and Ophthalmology 2019 Annual Meeting, researchers presented new findings on the utility—and the delivery—of bevacizumab in eye disorders.

May 02, 2019

The researchers wrote that that a numerically larger proportion of patients with myasthenia gravis (MG) stopped or reduced their doses of immunosuppressive therapies than started or increased, and that symptom improvement or worsening were the main reasons for changes to concomitant therapy.

May 02, 2019

While a study in healthy volunteers demonstrated bioequivalence of the 2 insulin products, to date, few direct comparisons of the biosimilar and the innovator have been available. A new study compared the efficacy and safety of treatment with each of the products in a retrospective analysis of hospitalized patients with type 2 diabetes and found that the reference insulin provided better fasting glycemic control than the biosimilar.

May 01, 2019

European elections will take place later this month, allowing EU citizens to select their representatives in the European Parliament. The elections, being held for the first time in 5 years, are particularly significant to the healthcare sector as European stakeholders seek to reduce disparities in access to care, guard against drug shortages, and ensure a sustainable market for pharmaceuticals.