IFAA, in conjunction with Med-IQ and ProPatient, has launched an educational series “Biosimilars For Rheumatoid Arthritis: What Do I Need To Know?,” which not only informs participants of the key differences between biologics and biosimilars, but it also provides helpful tips for patients preparing to have an open, and educated conversation with their healthcare provider.
A biosimilar is a drug that is designed to be very similar to an existing biologic (called the reference product). The key word is "similar"; they are not generic versions of biologics. To be a generic drug, the new treatment must be an exact copy of the product it intends to replicate. Treatments, like aspirin, are chemically manufactured with simple structures - this makes them simple to replicate into a generic form. A biologic and a biosimilar are not chemically manufactured. They are both produced by living cells – in other words, they are grown, not made, so their structure is very complex. Biosimilars have been on the market in Europe for several years, but only recently have come to market in the US and Canada.
*IFAA supports continued clinical testing of biosimilars in various patient populations to ensure the products are safe and effective.
**IFAA does not support an interchangeability at this time, as we do not believe there is enough clinical data to justify automatic switching from biologic to biosimilar.
Patients for Biologic Safety and Access (PBSA) is a national coalition representing more than 20 patient advocacy organizations working to ensure that the voices and interests of patients are heard as the FDA considers approval of a new category of drugs known as biosimilars. IFAA is a member of PBSA.Learn more about PBSA
Global Healthy Living Foundation/CreakyJoints "Healthy Biologics". up-to-date patient information regarding the substitution of biosimilar medications for the original innovator biologic medications. Visit Healthy Biologics
US Food & Drug Administration. The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act). Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. Learn more about the FDA regulatory process regarding biosimilars.
Alliance for Patient Access (AfPA) is a national network of physicians dedicated to ensuring patient access to approved therapies and appropriate clinical care. AfPA accomplishes this mission by recruiting, training and mobilizing policy-minded physicians to be effective advocates for patient access. While this is physician based, patients can find great resources on their site and can sign up for e-newsletters that provide monthly updates about legislative efforts involving biosimilars in each state. Learn more about AfPA and several related stakeholder coalitions.
The Biosimilars Forum was incorporated in Washington, DC, as a nonprofit organization to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The Biosimilars Forum will provide evidence-based information to inform and support public policies that encourage awareness, access, and adoption of biosimilars. Learn more about the Biosimilars Forum
The following questions are addressed in the video education module:
Do you still have questions? We are here to help! Submit your questionsvia the Biosimilars and Me online submission form. Then check back here periodically for the answers!
Disclaimer: The answers to the questions are based on IFAA's research on the topic and are not affiliated with the “Biosimilars For Rheumatoid Arthritis: What Do I Need To Know?" educational series.
Q: How often will I need to take a biosimilar? How is it administered?
A: A biosimilar is a drug that was designed to replicate an existing biologic that is currently on the market. Therefore, it's properties, including not only the way it works but also the way it is administered, will be the same. Biologics are made from living organisms and are very complex - so they are usually injected or infused into the body. Some newer treatments are in the form of tablets, called a Janus kinase (JAK) inhibitors; these treatments are not considered in the same class as biologics, and therefore, do not currently have biosimilar counterparts.
Q: How are biosimilars created? Have they undergone the same rigorous safety testing as the original biologic, given that they are not identical/bioequivalent?
A: The way biosimilars are initially created involves scientists taking the original biologic (or reference product) and breaking it down in a lab until they can identify the original molecular sequencing, resulting in a clone of the original product. Then they spend a long time trying to duplicate the manufacturing process to make sure the biosimilar is similar in both safety and efficacy to the original product. Once this is completed, they must test the product ina clinical setting (not multiple clinical trials) to demonstrate the biosimilar has no clinically meaningful differences from the original biologic. If successful, the trial data is submitted to the proper regulatory agency for review and approval to market publicly. So, no, a biosimilar does not have to go through the same rigorous safety testing as the original. The regulation process assumes if the biosimilar shows no clinically meaningful differences as the original drug, then there is no need to retest the product in patient trials. In saying this, if approved, the biosimilar product automatically adopts the clinical trial data that has been collected from the original product.*
Q: I have heard I will save money if I use a biosimilar instead of a biologic. Is this true?
A: More than likely, no. Any savings will start at a level much higher than we would see at a patient level - and by the time those savings trickle down to us we may be looking at saving the amount equivalent to a cup of coffee. As of now, biosimilars are not considered "interchangeable" with their biologic counterparts, and so they remain on the same pricing level as other innovative therapies. However, if in time they are ruled to be interchangeable** with their biologic reference product, patients may see slight savings because the product would move to a lower tier pricing level (like a generic), thus lowering out of pocket costs.
Patients can choose which topics are of most interest to them, then click on the link to learn more from medical professionals and Tiffany Westrich-Robertson, IFAA's CEO (and RA, axSpA patient, pictured above). Patients can also download the app, which will enable them to record questions they can use to help talk about biosimilars with their practitioner. NOTE: While the series mentions RA, the information is relevant to patients regardless of their diagnosis.
American College of Rheumatology (ACR)position on biosimilars.
Australian Government Department of Health/The Australian Government’s Pharmaceutical Benefits Scheme (PBS) provides reliable, timely and affordable access to a wide range of medicines for all Australians. Learn more
European Medicines Agency (EMA). The Agency is responsible for assessing applications from companies to market biological medicines for use in the European Union (EU), including biosimilar medicines. The European Commission issues decisions concerning the authorization of biosimilars on the basis of the scientific opinions from the EMA. Learn more
European League Against Rheumatism (EULAR)position on biosimilars.
Global Alliance for Patient Access (GAfPA) is the International Network of Physicians & Advocates for Patient Access, primarily working in Europe, Latin America, Asia, and Australia. Learn more
Biosim•Exchange. As one of Canada’s leading patient voices, Arthritis Consumer Experts (ACE)/JointHealth has created a reader-friendly information hub for consumers and health care professionals to get the latest biosimilars news and background analysis. The Biosim•Exchange provides research-based information on biosimilar safety and effectiveness to inform consumers - patients and report on public and private health insurance formulary policy or listing decisions. The site is extensive and includes several additional resources, including information on current policy efforts. Learn more about the Biosim-Exchange
Health Canada. Health Canada is the Federal department responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances. They are also responsible for regulating biosimilars in Canada. Learn more about biosimilars from Health Canada
Regardless of where you live, or how long these products have been on market, organizations advocating for patients can all agree that biologics have revolutionized treatments for rheumatic disease patients and that biosimilars will bring more choices and potential access for those who could not otherwise afford treatments. However, we also agree that utilization of biologics versus biosimilars should be part of a shared decision making process, inclusive of both the patient and their practitioner.
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Biologic or Biosimilar: Why does it matter?
The active substance of a biosimilar must be similar to the active substance of the original biologic (reference product). Since both are made using living organisms, both (yes, even the original biologic) will vary slightly from batch-to-batch. However, minor differences in clinically inactive components are allowable in biosimilars, which may cause unexpected immune reactions in patients.
This is particularly important given autoimmune/autoinflammatory diseases are heterogeneous in nature, which means there are no two cases exactly alike, even among patients within the same disease group. This uniqueness can make choosing the right treatment a challenge, especially when the patient does not present with typical disease, including those who develop cross over diagnoses or co-morbidities. If you are stable on a treatment you should consult your doctor and, together, make an educated decision about the benefits and risks associated with disrupting continuity of care.
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