It has been seven years since the passing of the Biologics Price Competition and Innovation Act, a provision of the Affordable Care Act that created the approval pathway for biosimilars in the U.S. To date, four biosimilar products have been approved by the FDA, compared to 23 products in the European Union where biosimilars have been in play since 2007.
European countries experienced a slow start (apart from Germany), likely due to a lack of awareness of biosimilar drugs among physicians and patients. As the healthcare community gained more knowledge regarding the potential to provide greater accessibility of biologic products and decrease healthcare costs, the biosimilars market in the EU experienced an increase.
Participating in biosimilar trials bring many benefits to investigators—in an expanding area of development, investigators can establish early expertise and serve as a resource to others. As demand increases, sites familiar with conducting biosimilar research will be positioned favorably as sponsors and CROs seek to work with investigators with firsthand experience.
There are operational challenges associated with conducting biosimilar trials, and it will be important for sites to be educated on the benefits and potential challenges of conducting this type of research. First and foremost, it is critical for site staff to understand biosimilar compounds and how they differ from generics. Compared to a generic drug, an exact copy of the originator, a biosimilar is sourced from a living organism and thus undergoes a multifaceted, complex manufacturing process. It is not likely these larger molecules will be replicated, signaling a more intensive research process.
To ensure protocol compliance, research sites should ensure they are given adequate training and receive ongoing support throughout the trial from the sponsor or CRO. The Biosimilars Forum recently presented the results of a survey at the DIA Biosimilars Conference that indicated major knowledge gaps among physicians regarding biosimilar product knowledge, understanding of the approval process and that issues pertaining to interchangeability exist. Moving forward, consistent engagement and in-depth education provided to the site will be crucial in furthering biosimilar research. Knowledge provided to sites will, in turn, be passed on to the patient, helping to boost enrollment rates.
Patient recruitment remains a considerable challenge particularly in biosimilar research, partly due to unfamiliarity among patients and healthcare providers. In a 2016 study conducted by Lieberman Research Worldwide, 70% of respondents indicated no awareness of biosimilar therapy. The survey was administered to patients, patients in advocacy groups, caregivers and the general population. Naturally, this limits the pool of potential patients to recruit from and will require effort from site staff to provide outreach and inform new patients to the potential benefits of bringing biosimilars to market.
A benefit worth noting to potential patients is that a placebo in biosimilar trials is not required. The patient would either receive the approved biologic medication or the investigational medication. In terms of safety and efficacy, a common concern among patients, the biosimilar will have undergone widespread lab testing to ensure quality is similar to the reference product. Of course, there are always potential risks involved when participating in any clinical study, and all information should be clearly conveyed.
In order to remain competitive and bring biosimilar studies through the pipeline, it will be important for research sites to remain informed on industry developments and work on educating all staff. It will be helpful to keep an eye on key players in the industry, including Sandoz, Teva and Pfizer. In recent years, there has been an increase of pharmaceutical companies either currently selling or planning to sell biosimilar products and it is likely more organizations will look to get involved.
Ultimately, the goal is to provide better health outcomes overall by stimulating competition and making alternative treatment options more available to patients. As biological products have been on the market for over two decades, a number of first generation products are already off patent protection. The global biosimilars market is expected to reach $10.9 billion by 2021, an increase of $7.5 billion since 2016, indicating huge business development potential for research sites.
Dr. Christophe Berthoux has been the chief executive officer at Synexus since September 2010. Synexus is the world’s leading site management organization (SMO), dedicated to the recruitment and management of clinical trials across the globe for over 24 years. Synexus is proud to be the patient’s choice for clinical research. Email comments and questions to email@example.com.
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