The 10th Annual SMi Biosimilars Conference

“Talk about the success first,” said Steinar Madsen, MD, medical director of the Norwegian Medicines Agency. “Forget the nonexistent problems.”
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.
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.
If and when the United Kingdom leaves the European Union, the Medicines and Healthcare Products Regulatory Agency is poised to provide its own review structure for biosimilars. 
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?
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.

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Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars® is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

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