SMi Biosimilars North America

When It Comes to Instilling Confidence, What's Said About Biosimilars Matters

September 27th 2019

Article

“Talk about the success first,” said Steinar Madsen, MD, medical director of the Norwegian Medicines Agency. “Forget the nonexistent problems.”

Arrow Declarations Are an Emerging Feature in the Biosimilar Patent Landscape

September 27th 2019

Article

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 26th 2019

Article

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.

With Brexit Looming, What Does the Future Hold for UK Biosimilars?

September 26th 2019

Article

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.

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

September 25th 2019

Article

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 25th 2019

Article

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.

Celltrion Weighs in on Biosimilar Uptake Challenges in the United States

November 19th 2018

Article

A key factor in overcoming barriers to United States market entry is sharing the positive experiences of both healthcare professionals and patients, explained HoUng Kim, Head of Strategy and Operations Division, Celltrion Healthcare during a presentation at SMi Biosimilars USA Conference in Iselin, NJ, that took place November 14-15, 2018.

Systematic Review Finds "Low Risk" of Safety Concerns or Loss of Efficacy Following Switch to a Biosimilar

November 17th 2018

Article

Being able to switch from a reference product to a biosimilar is important for 3 reasons, explained Hillel Cohen, PhD, executive director of scientific affairs at Sandoz, during his presentation at SMi Biosimilars USA Conference in Iselin, New Jersey, held November 14-15, 2018.

Experts Discuss BPCIA Litigation Confusion, Differences Between IPRs and PGRs

November 15th 2018

Article

Experts from Venable, Alkermes, and Novartis provide updates to the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and explain the differences between inter partes review (IPR) and post grant review (PGR) litigation.

Can the Biosimilar Market Achieve Long-Term Sustainability?

November 15th 2018

Article

During the first day of the SMi Biosimilars Meeting held in Iselin, New Jersey, from November 14-15, 2018, Christina Yunis, global biosimilars market development lead at Pfizer, discussed the sustainability of and challenges seen in the biosimilars market from an industry perspective.