What are Biologics and Biosimilars?
We explain the difference between biologics and biosimilars and showcase Teva’s innovative work in this space
Biologics are complex medicines made from living cells or organisms. With the potential to deliver precise and personalized treatment, they can provide more treatment options for patients. The US Food & Drug Administration (FDA) characterizes them as a diverse category of products that are generally large and complex molecules.
Examples of biologic medicines include gene therapies, transplant tissues, recombinant proteins, stem cell therapies, and monoclonal antibodies. Biologics are becoming important in the treatment of autoimmune diseases including diabetes, rheumatoid arthritis, multiple sclerosis and Crohn's disease, while biological therapy for cancer uses the body’s own immune system to kill cancer cells.
Biologics are produced by biotechnology and other cutting-edge technologies. Gene-based and cellular biologics are often at the forefront of biomedical research and may be used to treat a variety of medical conditions for which no other treatments are available, according to the FDA. Because of their complex nature, biologics remain one of the most expensive options in healthcare and the yearly cost of a biologic can exceed $500,000.
How do biological products differ from conventional drugs?
In contrast to most drugs that are chemically synthesized and have known structures, most biologics are complex mixtures that are not easily identified or characterized, says the FDA.
The Biotechnology Innovation Organization explains the difference . Conventional drugs are typically manufactured through chemical synthesis, which means that they are made by combining specific chemical ingredients in an ordered process. These drugs generally have well-defined chemical structures, and a finished drug can usually be analyzed to determine all its various components.
By contrast it is difficult, and sometimes impossible, to fully characterize a complex biologic by testing methods available in the laboratory.
What are biosimilars?
Biosimilars are biological medicines that are highly similar to already approved biological medicines, says the European Medical Agency (EMA). Biosimilars are approved according to the same standards of pharmaceutical quality, safety, and efficacy that apply to all biological medicines.
Because biosimilars are made in living organisms there may be some minor differences from the reference medicine. These minor differences are not clinically meaningful – in other words, no differences are expected in safety and efficacy, says the EMA.
The approval process for biosimilars is more streamlined than it is for biologics, as the data submitted only needs to demonstrate its clinical and efficacy equivalence to the reference biologic. Because of this abbreviated approval process, biosimilars may be less expensive than the reference biologic.
The Association for Accessible Medicines confirms that biosimilar competition has lowered costs for both reference products and their biosimilars. Biosimilars alone generated $9.4 billion in savings throughout 2022 and $23.6 billion since 2015. But, much more importantly, in IQVIA’s Global Use of Medicines Report for 2023, biosimilars are projected to generate $290 billion in savings around the world through 2027.
This is potentially game-changing news for patients and healthcare systems.
What is Teva’s footprint in this area?
Together with creating original biologic medicines, Teva is investing in biosimilars as part of its Pivot to Growth strategy. A focus on biosimilars is also a natural progression for Teva following its role in the development of the generic medicine industry over the past 40 years, combining a strength in generics with a knowledge of innovative medicine.
As a global leader in pharmaceuticals and as an integral part of its Pivot to Growth strategy, Teva is making a commitment to the emerging biosimilar market. Teva currently has 11 innovative assets and 16 biosimilars in its pipeline. Explore it here.
Find out more about Teva’s work in biologics and biosimilars around the world.
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Read More
- Go behind the scenes at our laboratory to explore the different processes involved in creating biosimilars
- Trace the history of biologics, which were first discovered by two German scientists in the 1890s
- Interested in getting involved in the work that we do? Explore a career at Teva
