Advances in pharmaceuticals continue to evolve – quickly – helping to better treat complex health conditions, such as cancer, multiple sclerosis, and hemophilia. Two types of pharmaceuticals continuing to grab headlines are biologics and biosimilars.
Where biologics have been around for over one hundred years, making their debut in the 19th century, biosimilars are newer to healthcare, with the first globally-approved biosimilar making its premiere in the EU in 2013 and the U.S. Food and Drug Administration (FDA) approving the U.S.’s first biosimilar product two years later.
There’s no doubt that biologics have changed the way we prevent, diagnose and treat medical conditions and diseases. However, biosimilars “have the potential to enhance treatment accessibility,” according to Pfizer. Additionally, with many biologics’ patents about to expire, pharmaceutical companies are facing an interesting crossroads when it comes to biologics and biosimilars.
But, before we get to the future of medicine, let’s take a look at biologics vs. biosimilars.
What Are Biologics?
Many biologics have been around for over one hundred years with the emergence of vaccines, such as those for rabies, typhoid, and smallpox. Fast forward to 1982, and human insulin became the first FDA-approved bacteria-generated biologic. And, recently, the FDA approved the Moderna COVID-19 vaccines for booster doses on March 29, 2022.
These types of drugs – commonly referred to as biologics – are produced using a living system, such as components from plants, animals, humans, and microorganisms. Biologics contain more complex molecules than small molecule drugs, like aspirin or antihistamines. Often, biologics are administered through injection or infusion.
What is an example of a biologic?
In addition to many vaccines, here are some other biologic uses to keep in mind:
- Gene therapies
- Tissues for transplants
- Blood products, such as platelets
- Recombinant proteins, such as insulin
- Stem cell therapies
- Monoclonal antibodies that help the immune system treat autoimmune diseases or fight cancer
According to a recent study, the global biologics market is expected to reach $749.62 billion by 2028.
What Are Biosimilars?
As we mentioned above, biosimilars are newer to the pharmaceutical market. But, these drugs have already made a big impression during this short tenure.
A biosimilar is a biological product, serving as an almost identical copy to the FDA-approved original biologic product. This original biologic product is referred to as a “reference product.”
The biosimilar product must not have any meaningful differences in terms of quality, effectiveness, and safety from the reference product. Only minor variations in clinically inactive components may exist.
Source: FDA.
Biosimilars may be put into the market once the patent expires for the reference product (i.e., the biologic product copied by the biosimilar). If biosimilar manufacturers put the drug into circulation while a biologic’s patent is still effective, then the biosimilar manufacturer runs the risk of violating the active patent.
What is an example of a biosimilar?
Let’s look at some examples of FDA-approved biosimilar products.
Humira is a popular brand name drug primarily used to treat rheumatoid arthritis and Crohn’s disease. However, Humira frequently tops the list for the most expensive drugs with a $9,065 average monthly cost. Since the drug’s debut in 2014, the manufacturer’s cost has increased by 138 percent.
Additionally, Humira makes patient access difficult since most health plans place this drug in higher-tier formularies – with higher copays and prior authorization requirements.
Over the past few years, however, several Humira biosimilars have been approved by the FDA, including:
- Yusimry, approved in December 2021
- Hulio, approved in July 2020
- Yusimry, approved in November 2019
- Hadlima, approved in July 2019
- Hyrimoz, approved in October 2018
- Cyltezo, approved in August 2017
- Amjevita, approved in September 2016
As reported by the Kaiser Family Foundation, biosimilars provide approximately a 30 percent savings over brand biologics; however, biosimilars have “the potential to reduce spending by more than $100 billion dollars” through 2024.
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Are Biosimilars the Same as Generic Drugs?
While biosimilars and generic drugs are versions of a brand name drug, and often more affordable than that brand name drug, they are not the same.
Biosimilars and generic drugs are both approved by the FDA, but through different clinical trials and approval processes. For example, generic drug manufacturers must prove that they are chemically identical to the brand name drug, demonstrating that the generic is essentially the “bioequivalent” of the brand name drug.
Biosimilars, on the other hand, are not chemically equivalent as they contain components from living organisms. Like generics, biosimilars still require testing and approval by the FDA. However, they are typically more expensive than generics, but less expensive than the reference product (or brand name drug).
What Is a Biosimilar Interchangeable Product?
Now that biologics vs. biosimilars has been covered, let’s take biosimilars a step further. Biosimilars may be interchangeable with the brand name drug, or reference product, if the biosimilar meets additional requirements. These requirements are outlined in the Biologics Price Competition and Innovation Act.
To be interchangeable, a “manufacturer of a proposed interchangeable product will need to provide additional information to show that an interchangeable product is expected to produce the same clinical result as the reference product in any given patient.” As a result, according to the FDA, a product approved as an interchangeable biosimilar “means that the FDA has concluded it may be substituted for the reference product without consulting the prescriber.”
So, for example, suppose a patient self-injects a drug for rheumatoid arthritis. To originally receive the biosimilar instead of the brand name drug, they would need a prescription from their doctor. However, once a biosimilar interchangeable drug is approved by the FDA, then the pharmacist could substitute the interchangeable biosimilar for the brand name drug without consulting the patient’s doctor.
What’s Next? The Future of Biologics vs. Biosimilars
As we continue to see rising drug prices, the future of biosimilars is bright. With biosimilar sales topping $15 billion in 2020, the industry is expected to grow rapidly – doubling in size to $30 billion by 2025 and doubling again to $60 billion by 2029.
However, the difference between biologics vs. biosimilars continues to develop, and with this growth pace, expect change in the clinical, manufacturing, regulatory, and commercial markets as well as in research and development. But through increased competition, decreased overall cost, and increased access and utilization for patients, biosimilars just may be the thing that the healthcare industry needs.
