Biosimilars 101: Lowering Healthcare Costs
For many Americans, the ever-rising healthcare costs have made effective and state-of-the-art healthcare inaccessible and unaffordable. According to a study conducted by the American Medical Association, America spent almost $3.5 trillion dollars on healthcare in 2017, nearly 2 times that of comparable countries. This can be partially contributed to biologics, an innovative and complex medication that’s grown and extracted from a living cell. Examples of a biologic include:
Vaccines
Gene Therapy
Cell Therapy
Recombinant Antibodies – synthetic immune cells
The NIH projects that the oncology drug market will reach $112 billion by 2020 predominantly due to the cost of biologics. As a result of the price increases, a new class of drugs has been developed: biosimilars.
A biosimilar is a product designed to mimic existing biologic medications. According to the FDA, biosimilars must demonstrate no clinically meaningful differences in safety and efficacy from the reference biologic product (but minor variations in inactive components are permitted). The essential structure (amino acid chain) is the same, but the mechanisms of action can be different. The development of biosimilars takes around 7-8 years and 200 million dollars to develop compared to 10+ years and about $1.2 Billion for Biologics.
The FDA approved its first biosimilar, Zarxio, in March of 2015 which is to help patients receiving chemotherapy that suppresses bone marrow fraction.
Biosimilars have the ability to dramatically decrease costs in healthcare. In a study done by NIH, it is estimated that in ten years, biosimilars will have a cost savings potential of about $54 billion (or a range of $25 billion to $150 billion). The exact number will be based on the evolving regulatory and competitive landscapes.
There are concerns with biosimilars such as:
They are not tested in robust large phase III clinical trials as Reference Biologics.
Manufacturing conditions cannot be rigidly controlled, and biologic variability may be present.
May generate immune responses (antibody formation by the body)
Extrapolation, in which information and conclusions from studies in one group of patients is extended to make inferences for another population of patients.
Inspite of the above concerns, the broader scientific and physician communities believe that biosimilars present the opportunity to significantly improve access, affordability and overall patient outcomes.
If you are interested in how biosimilars may effect your cancer treatment(s), you can ask your doctor the below questions:
What is your stance on biosimilars?
How will I know if I’m getting a biosimilar instead of a biologic?
How is the biosimilar tested for safety and efficiency?
What are the cost differences between treatments of biosimilars and biologics?
How should we decide and who decides if I should use a biosimilar versus other treatment options?
Will using a biosimilar have any effects on my treatment outcome?
Written By: Aishvarya Godla
Reviewed By: Srilata Gundala, MD
