SMi 9th Annual Biosimilars and Biobetters Conference

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. 
The SMi 9th Annual Biosimilars and Biobetters Conference was held in London from September 26-27, 2018, and featured the experience of key opinion leaders and industry experts, as participants aimed to assist stakeholders in evaluating market access opportunities and commercialization strategies.
 
Attendees at the 2018 SMi Biosimilars and Biobetters Conference had the opportunity to hear about topical case studies with marketed biosimilars, learn more about what can be done to convince payers, prescribers, and patients to switch to biosimilars, and explore the future of biosimilars expected to enter the market. Those who were unable to attend in the UK can depend on The Center for Biosimilars to provide the most in-depth coverage, including articles and video interviews, from the meeting.

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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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