Kelly Davio


Arrow Declarations Are an Emerging Feature in the Biosimilar Patent Landscape

September 27, 2019

In the US context, legal issues surrounding patents are often cited as one of the main hurdles to biosimilars. Despite the fact that patents on innovator drugs are often fewer in Europe, the patent landscape in the European Union remains complex and continues to evolve. During the SMi 10th Annual Biosimilars Conference, Gregory Bacon, DPhil, GDipIPLaw, partner at Bristows LLP, gave attendees a closer look at one emerging feature of the EU patent landscape that is of particular concern to biosimilar developers: the Arrow declaration.

Biosimilar Developers Have the Chance to Innovate With Device Design, Novartis Leader Says

September 26, 2019

Innovation is not always the first term that comes to mind with respect to biosimilars; after all, having no clinically relevant differences between products is at the heart of biosimilarity. However, as Sebastian Maag, device project leader for Novartis–Sandoz GmbH, told attendees during the second day of the SMi 10th Annual Biosimilars Conference, biosimilar developers have the opportunity to introduce innovations with the design of their devices for drug delivery.

IQVIA Analyst Looks at Current Developments and the Decade Ahead for Biosimilars

September 25, 2019

The global biosimilars market is beginning to take on a more defined shape as blockbuster therapies lose their exclusivities, the United States sees the entrance of the first anticancer biosimilars, and Europe gains experience and savings with adalimumab biosimilars. But what will the coming decade hold in terms of new development projects and global sustainability?

Biogen Director Shares Lessons Learned From EU Biosimilar Commercialization

September 25, 2019

During the opening day of the SMi 10th Annual Biosimilars Conference, held September 25-26 in London, United Kingdom, Dan Cohen, Biogen’s regional senior director of biosimilars for the United Kingdom, Ireland, and the Netherlands, shared his experience with anti–tumor necrosis factor biosimilars in general, and with biosimilar adalimumab in particular, in the EU marketplace.

Paper by European Regulators Foresees "Continuing Reduction in Clinical Data Requirements" for Biosimilars

September 24, 2019

This month, Elena Wolff-Holz, MD, PhD, chair of the European Medicines Agency’s (EMA’s) Biosimilar Medicinal Products Working Party, together with coauthors from the EMA and the Federal Institute for Drugs and Medical Devices in Germany, published a new paper in which the team outlines the extent of clinical confirmation of biosimilarity, taken together with analytical and functional data, that is considered necessary for biosimilar drugs to be approved in Europe.

In Updated Phase 3 Results, Innovent's Bevacizumab Biosimilar Shows Similarity to Avastin

September 23, 2019

During last week’s 22nd Annual Meeting of the Chinese Society of Clinical Oncology, held from September 18-22 in Xiamen, China, drug maker Innovent Biologics presented updated results for its proposed bevacizumab biosimilar, IBI305, in an oral session.

Celltrion Receives Positive CHMP Opinion for Subcutaneous Infliximab Biosimilar, CT-P13

September 23, 2019

During its September 2019 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a change to Celltrion’s marketing authorization for its biosimilar infliximab, CT-P13, sold in Europe as Remsima.

Studies Report on Efforts to Optimize Rituximab in MS, NMOSD

September 21, 2019

While rituximab does not carry indications for the treatment of multiple sclerosis (MS) or aquaporin-4-positive (AQP4) neuromyelitis optica spectrum disorder (NMOSD), the CD20-depleting therapy and its biosimilars are commonly used off-label, as the therapy has been demonstrated to be effective in reducing relapses in MS as well as in reducing the frequency and severity of attacks in NMOSD.

Time to Take a Science-Based View of Biosimilar Interchangeability, Paper Argues

September 20, 2019

A team of authors points out that, given batch-to-batch variation of all biologics that can be enhanced by manufacturing changes, no batches of biologics can be considered identical to one another. However, “they may be considered essentially equal and therapeutically indistinguishable,” which points to a clinically acceptable range of structural heterogeneity for any biologic.