The failure rate of biosimilars in clinical trials is considered high because of the complex manufacturing process and the high variability expected for biologics. With associated development costs for a biosimilar estimated to be $100 million, there is a high risk-cost relationship in the establishing clinical biosimilarity.
The failure rate of biosimilars in clinical trials is considered high because of the complex manufacturing process and the high variability expected for biologics. With associated development costs for a biosimilar estimated to be $100 million, there is a high risk-cost relationship in the establishing clinical biosimilarity.
A recent essay in the November 30, 2017 issue of Clinical Research News suggests that the efficient use of modeling and simulation (M&S) allows decision making that will increase the likelihood of successful outcomes in studies of biosimilars. The authors present case studies using M&S in biosimilar studies of adalimumab, rituximab, and pegfilgrastim, and show how M&S could optimize biosimilar trial success rates.
In use for more than 2 decades, M&S in clinical trials of biosimilars could increase study efficiency by allowing for robust results, a shorter duration, involvement of fewer patients, and reduced cost, and could provide a competitive advantage for drug sponsors seeking to improve their drug development processes and decision making.
Using M&S to evaluate pharmacokinetic/pharmacodynamic (PK/PD) relationships can support a biosimilar program, the authors note. Model-based simulations are increasingly used to optimize the design of clinical PK, PK/PD, and outcome studies for biosimilars by leveraging quantitative knowledge of the new product against the originator. The FDA has acknowledged that M&S can be useful when designing studies, for example, to determine dose selection and define the acceptable limits for PD similarity.
M&S can make use of available data in the public domain and in-house information on the proposed biosimilar product to make efficient decisions on study design that will increase the probability of a successful outcome, the authors state. “By integrating information across dose levels, using longitudinal PK/PD and disease progression models, uncertainty can be reduced in the estimated PK, PD, efficacy and safety endpoints,” they write. “The models allow variability within, and between, subjects to be estimated, and it is also possible to simultaneously account for multiple factors to explain variation in exposure and response across individuals, including the formation of anti-therapeutic antibodies.”
Using M&S for clinical trial simulation, different study designs can quickly be explored in computer simulations as to dose, sample size, study duration, reduced sampling schedules, inclusion and exclusion criteria, and the choice of a statistical evaluation method. The influence of an expected difference between the originator and new product on the required sample size can easily be calculated with M&S, the authors note, and the most cost-effective design with a sufficient probability of a successful outcome can be chosen. These methods can also be used to apply results across study populations and therapeutic indications, furthering the clinical development of biosimilars.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo
November 7th 2024For the first time, Skyrizi (risankizumab-rzaa) has replaced Humira (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Panelists Stress Stakeholder Education to Build Confidence in Biosimilars
October 31st 2024By expanding educational initiatives to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.