The healthcare industry is always focused on advancing treatments for patients, but this upcoming year is a particularly exciting and optimistic time as nearly 10 biosimilars are expected to enter the U.S. marketplace. To put into context, the U.S. Food and Drug Administration (FDA) has approved more than 300 biologics since 1982 and biosimilars have only come to market in the past few years. Since biosimilars are proven to work in the same way as a reference biologic, patients can expect no clinically meaningful differences in therapeutic effect.
Another benefit to biosimilars entering the marketplace is that patients will have more access and more treatment options, at a potentially lower cost. Take insulin for example: it’s a biologic that many people are familiar with. As biologics, insulins are subject to biosimilar competition, which helps to create an easier pathway for more affordable biosimilars and Interchangeable biosimilars to enter the market. In fact, a recent study found that insulin biosimilars have expanded treatment options for diabetes and could potentially reduce medical costs, especially in low- and middle-income countries. Biosimilars have, and will continue, to provide significant savings to the healthcare industry, potentially creating $238 million in average annual out-of-pocket savings for patients.
Biosimilars are anticipated by many to have a major impact on the future of healthcare, by optimizing innovation in the market, leading to lowered medication pricing, and allowing greater access to the medication for patients. In fact, it’s estimated that increased biosimilar use will also reduce patients out of pocket costs – by up to 17 percent on average.
As healthcare professionals, it’s important we take the time now to prepare for the upcoming launch of biosimilars. By educating ourselves ahead of this wave of biosimilars, we can better understand how to effectively utilize them to help patients. In particular, access to interchangeable biosimilars may help improve patient outcomes and are an important step in fostering a more sustainable U.S. healthcare system.
Patients & treatment decisions
Oftentimes, patients use specific medications based on what their provider prescribes for them. As we look to biosimilar uptake, a recent research paper found that it would be more successful and faster if efforts were made to educate patients and their providers. Research also shows that patients would like to discuss biosimilars with their healthcare provider to better understand the treatment. It’s critical that healthcare providers are setting time aside to help educate patients on biosimilars before initiating the switch from a reference product. It is also imperative to increase the understanding of biosimilars by ensuring that tailored information is easily available for both patients and HCPs.
While it’s clear that biosimilars have the potential to transform the healthcare system, the question now is: what can we do to educate healthcare providers managing this transition, as well as patients, so they can experience their full benefit?
A better understanding and confidence in biosimilars and interchangeability
The biosimilar development process is inherently complex and requires a high degree of technical innovation and regulatory expertise. Since biologics are grown from living organisms, it is impossible to develop an identical copy of the reference product. This is also true batch to batch for the reference product, and for biosimilars making new versions of the reference product. At Boehringer Ingelheim, we’re proud to manufacture our biologic medicines at our site in Fremont, California. We are one of the largest producers of biologic medicines in the world, with over 37 years of experience in biotechnology. Through novel biologics and biosimilar programs, we hope to increase the availability of safe, effective, high-quality therapeutic options to patients worldwide.
It’s important to know that all FDA-approved biological products, including reference, biosimilar, and Interchangeable biosimilar products, undergo a rigorous evaluation to ensure that both HCPs and patients can rely on their efficacy, safety, and quality. To achieve an Interchangeable designation, the FDA requires at least one additional study of multiple switches in patients – known as an Interchangeability study. According to the FDA, prescribers and patients “can expect that the Interchangeable product will have the same clinical result as the reference product in any given patient.” And patients “can be confident in the safety and effectiveness of an Interchangeable product, just as they would be for an FDA-approved reference product.”
Switching from a reference product to a biosimilar can lead to patients feeling anxious and apprehensive, but this can be mitigated if patients are well informed and can have an open dialogue with their healthcare provider around biosimilars and their use. Patients want to be reassured that biosimilars a safe, effective treatment option. As healthcare professionals, we can help patients feel more comfortable switching to biosimilars.
The future of biosimilars
By adopting the use of biosimilars, it will serve the entire healthcare ecosystem. Patients can feel reassured that they can expect no clinically meaningful differences in therapeutic effect since biosimilars are proven to work in the same way as a reference biologic. From a clinical perspective, biosimilars are proven to be a valuable option in managing patient care and healthcare providers can feel confident in their use. By enabling early use of the right biologic medications, access to biosimilars may help improve patient outcomes. Additionally, biosimilar medications may enable the reallocation of resources to other patient care areas by possibly offering more affordable alternative. Thanks to biosimilars, the healthcare system will become more competitive. Manufacturers will be motivated to lower the pricing of their products to preserve or grow market share when the number of treatment options for a certain disease or condition rises.
Biosimilars can seem like a foreign concept and there is work to be done to enable clinicians and patients to have confidence in biosimilars. First, additional resources to help us educate patients are needed to reinforce the trusted collaboration between a patient, their healthcare provider and their pharmacist. At Boehringer Ingelheim, we are providing educational resources, including our website, to help patients, healthcare providers and pharmacists become familiar and confident in biosimilars.
I’m proud that Boehringer Ingelheim has such a deep understanding of and commitment to the development biosimilars — including conducting additional studies to meet the requirements of an Interchangeability designation. In fact, nearly two-thirds of the world’s 20 leading pharmaceutical companies trust Boehringer Ingelheim as a contract manufacturer of their proprietary biologic medicines.
It’s an exciting moment right now and it’s great to see biosimilars coming to the market. I’m looking forward to all that is to come from this change. Boehringer Ingelheim is committed to offering the highest quality products and bringing more health to patients and their families. Through our biosimilar program, we hope to increase the availability of safe, effective, high-quality therapeutic options to patients worldwide.