In recognition of the second annual Global Biosimilars Week – a social media awareness campaign to help raise awareness and advocate for biosimilars – we spoke to Sonia T. Oskouei, PharmD and Vice President of Biosimilars at Cardinal Health. Oskouei leads the company’s overall biosimilars strategy and sits on the board of directors of the Center for Biosimilars. Here, she discusses the significant impact biosimilars will have on the future of healthcare.
Q: Let’s start with the basics: how do biosimilars compare to biologics and why are they important for healthcare?
A: A biosimilar is just as safe and effective as an existing FDA approved biologic (called a “reference product”). Unlike generics, which are made from chemical compounds and can be replicated identically, biologics are large, complex molecules that are made from living cells. Because they are made from living cells, there is inherent variability associated with them; they cannot be replicated identically, and that is why they are called “biosimilars”. In the United States, biosimilars are currently used to treat patients with cancer, kidney disease, and autoimmune diseases, such as rheumatoid arthritis and Crohn’s disease.
Advances in biosimilars in the United States began when the Organic Products Price Competition and Innovation Act was enacted in 2010, which established an abbreviated path to FDA approval for biosimilars, with the goal of enabling better patient access to high-quality products at lower cost.
Five years later, the first biosimilar was approved by the Food and Drug Administration (FDA). Since then, 30 additional biosimilars, covering the therapeutic areas of oncology, rheumatology, diabetes and, more recently, ophthalmology, have been approved. Industry analysts say biosimilars set to cut drug costs in the United States by $ 133 billion by 2025.
Q: If the biosimilars are not exactly the same as their reference products, how do we know they will work the same in patients?
A: The FDA requires biosimilars to meet rigorous approval standards, which means patients and healthcare professionals can be assured of their safety, efficacy, and quality, just as they would with products. reference. The approval process requires manufacturers of biosimilars to submit data demonstrating that there is no clinically significant difference from the reference biologic. Although the data requirements for biosimilar approvals differ from the requirements for reference biologics, biosimilars have equally stringent approval standards.
Q: What does “interchangeability” mean and why is it important?
A: Interchangeability is a regulatory designation for biosimilars that is unique in the United States The designation allows for ‘pharmacist-level substitution’, which means that a pharmacist can replace the branded / reference biologic with the biosimilar with state laws, without consulting the prescribing physician (similar to the way pharmacists routinely substitute generic drugs for brand name drugs). For biosimilars dispensed in the retail pharmacy and covered by the patient’s pharmaceutical guarantee (such as insulin and Humira biosimilars), the interchangeability designation is important, as it will allow pharmacists to help patients access options. high quality processing at the lowest cost.
All biosimilars, whether interchangeable or not, meet the same stringent regulatory approval standards set by the FDA.
Q: Why are biosimilars important to the U.S. healthcare system?
A: Biologics are the most expensive drugs in the United States. For a patient managing one or more complex illnesses, biologics can cost tens of thousands of dollars each year. Biosimilar prices are expected to be 15-30% lower as their benchmark products. The entry of biosimilars into the market leads to greater competition, thereby reducing costs and increasing the accessibility and affordability of these essential treatments.
We’re already seeing how biosimilars cut costs: in 2020 alone, biosimilars checked in $ 7.9 billion (more than three times the $ 2.5 billion saved the previous year), with savings expected to increase significantly over the next several years as more biosimilars enter the market for new reference biologics.
Q: If biosimilars are much more affordable, why aren’t they more widely used?
A: It’s no secret that the US healthcare market is complex; more precisely, the dynamic of the payer who dictates the mode of reimbursement of drugs is complex. Although biosimilars are generally cheaper, stakeholders’ incentives are not always aligned to enable or support the adoption of biosimilars. In addition to financial considerations, persistent gaps in the knowledge of some key stakeholders (including providers and patients) regarding biosimilars can be a barrier to adoption. Lack of knowledge of biosimilars contributes to greater hesitation vis-à-vis these products. This is a key driver of Congressional and FDA activities, including the passage this year of the Biosimilars Education Promotion Act, intended to increase the education and awareness of providers.
Q: How many biosimilars are on the market in the United States?
A: Today, there are 31 FDA approved biosimilars in the United States, of which 20 are available in the market. (The remaining products have delayed launches primarily due to patent litigation settlements between the biologics and reference biosimilars.) Of the 20 biosimilars available, 17 are used for cancer-related treatments; the other three are used to treat autoimmune diseases.
All currently available biosimilars are primarily products administered by healthcare professionals, which are primarily administered in a hospital or medical clinic. However, biosimilars are on the verge of expanding into two new therapeutic areas: diabetes and ophthalmology. Semglee (insulin glargine-yfgn), which is the first FDA-approved biosimilar insulin with an interchangeable designation to treat diabetes, will help lower costs for one of the more expensive classes of drugs on the market. It may also mean that millions of American diabetic patients may soon have access to high-quality, low-cost treatment options for insulins. It’s important to note that this product – expected to launch later this year – will also be the first biosimilar available in retail pharmacies.
In September, the FDA approved the first ophthalmic biosimilar to treat retinal conditions, including neovascular age-related macular degeneration (AMD), which is the leading cause of blindness in the United States, affecting approximately 11 million Americans. . This product is expected to be launched next summer. It has the potential to dramatically reduce AMD treatment expenses, which is associated with a significant financial burden on patients, with estimates showing that treatment can cost a patient as much as $ 24,000 one eye per year.
This is really exciting: The expansion of biosimilars into these new product categories, and into retail pharmacies, may represent a tipping point for the widespread adoption of biosimilars across the United States over the next few years.
Q: What does all of this mean for the future of healthcare?
A: Making high-quality health care accessible to all Americans is one of the most significant challenges facing the American health care system. Biosimilars have the potential to dramatically improve health equity by stimulating competition and reducing costs, with the ultimate goal of enabling more patients with severe and chronic illnesses to access the care they require. need.
These agents are essential in helping to cope with the significant financial burden associated with the treatment needed by millions of patients – in the United States and around the world. The Organic Price Competition and Innovation Act was intentionally created with two key words in its name: “competition” and “innovation”. These terms go hand in hand: One of the most exciting promises of biosimilars is the ability to ultimately unlock the healthcare dollar to make room for the next generation of innovative treatments that will further improve healthcare delivery and help patients. people to live longer and healthier lives. .
Q: How does Cardinal Health work with biosimilars?
A: Cardinal Health distributes all released biosimilars to all healthcare sites where they are approved for use, including physician offices, healthcare systems, and retail and specialty pharmacies nationwide. We provide the educational, analytical and technological tools (including a new interactive tool which provides key guidance on navigating state-to-state interchangeability laws) to help our supplier and pharmacy networks make informed decisions about how they can adopt biosimilars.
In addition, our Specialty Solutions business works directly with biosimilar manufacturers to help them navigate the path of clinical development, regulatory approval and commercialization.
About Cardinal Health
Cardinal Health (NYSE: CAH) is a pharmaceutical distributor, a global manufacturer and marketer of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. With 50 years of business, operations in more than 35 countries and approximately 44,000 employees worldwide, Cardinal Health is essential to care. Information about Cardinal Health is available at cardinalhealth.com.
Media: Marcia Frédéric, [email protected] and (614) 757-9968
Investors: Kevin Moran, [email protected] and (614) 757-7942
SOURCE Cardinal Health