SMi Biosimilars North America

“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.

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.

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 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.

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.

In the United States, biosimilar launches have been met with disappointment over what many view as too-shallow discounts to reference products’ list prices. However, as Aurelio Arias, a consultant at IQVIA, explained during the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, the substantial savings that the European market has realized with biosimilars are not necessarily reflected in list prices, either.

Recent weeks have seen heightened debate over the need for phase 3 confirmatory trials for biosimilars, with some stakeholders calling these trials unnecessary and others going so far as to call them unethical. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Uwe Gudat, MD, who serves as head of clinical safety and pharmacovigilance at Fresenius Kabi, weighed in. “The subject I raise is rather provocative,” he acknowledged.

While every biologics manufacturer has its own standards against which it measures a product’s consistency over time, there is an increasing need for harmonization of these in-house standards with a public standard that can serve as a benchmark for the reference product and all biosimilars. This, explained Meenu Wadhwa, PhD, is where World Health Organization (WHO) international standards come in.

In recent years, payers in Europe have been increasing their scrutiny of new therapies as increasingly high-cost drugs come to the market. And while the United States does not have the same cost constraints as the single-payer health systems, it too faces heightened pressures to lower costs in order to afford innovative therapies.

Fraser Cummings, MBChB, DPhil, led one of the first clinical teams to switch patients receiving the reference infliximab (Remicade) to CT-P13 (Remsima) in UK clinical practice. During the SMi 9th annual conference on Biosimilars and Biobetters, held September 26-27 in London, United Kingdom, Cummings explained his experience with this switch in his gastroenterology clinic, and looked ahead to the arrival of adalimumab biosimilars in the National Health Service (NHS).

In the early days of the market, explained Michael Muenzberg, MD, biosimilar developers had to decide between 2 business models, which he termed a “follow-on model” and a “biogeneric model.” The former involves investing in device design, safety data, and sales and marketing to compete on aspects other than price alone. The latter model, which has not emerged as a dominant option in Europe, is simply to make a product as cheap as possible.

In a Thursday session of the SMi Biosimilars North America 2017 conference, Cindy Cao, PhD, executive director and head of United States regulatory affairs at Sandoz, looked ahead to the advent of interchangeable biosimilars.

Mkaya Mwamburi, MD, PhD, MA, president and CEO of the biotechnology consulting firm profecyINTEL, said in a presentation at the 2017 SMi Biosimilar North America conference that manufacturers of originator biologics are taking the lead on biosimilar development.

In a Wednesday session of the SMi Biosimilars North America 2017 conference, Gary Cupit, PharmD, senior advisor to the investment bank Frontcourt Group, gave biosimilar manufacturers his perspective on the market access challenges facing biosimilar developers.

Steinar Madsen, MD, medical director of the Norwegian Medicines Agency, shared lessons learned from the Norwegian experience with biosimilars in a Wednesday talk at the SMi Biosimilars North America conference.

At a Wednesday session of the SMi Biosimilars North America conference, Chrys Kokino, MBA, head of Mylan’s global biologics commercial division, said that biosimilars can be part of improving access to and affordability of biologic therapies for patients worldwide, but also highlighted the hurdles that biosimilar developers will have to overcome as they seek to gain a foothold in the US marketplace.