Biosimilars and generic drugs are not the same. One is “highly similar” and the other is an exact copy.
Though these cats in the images look the same, they are actually very similar and not exactly the same.
Whereas, a generic drug is manufactured using the exact same chemical ingredients in the exact same formula to be exactly the same as an existing FDA-approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.
Biologic drugs are made using recombinant DNA technology and living cells—large, complex proteins that play roles in the inflammatory process and the immune process.
Biosimilars and Generic Manufacturing
A biosimilar drug is a copy of a biologic drug that uses the same amino acid starting materials and the same step-by-step process as the “reference” biologic drug.
A biosimilar is manufactured by genetically modifying a cell so that a cell line can be used to produce the protein needed for the drug. A cell line is a culture of cells that will grow indefinitely if given the appropriate environment. The protein necessary for the drug is separated from the cell line and purified.
This process creates a drug that is highly similar to the original reference biologic drug, but not identical. Even though the same exact process is followed every time there may be slight changes from batch to batch. These variations are normal and acceptable, according to the FDA. Every manufactured lot of a biosimilar drug must meet the same high standards to be pure, safe, and effective.
FDA Approval of Biosimilars
As stated earlier, biosimilar drugs are “highly similar” to the drug they are copying, but not exactly the same the way generic drugs are. A biosimilar drug will not be approved by the FDA unless it is highly similar to an already approved FDA biologic drug which means that it must not have any clinically meaningful differences in safety, purity and potency (effectiveness) from the reference product.
Patents on Biologic Drugs
Patents on many high-priced biologics are beginning to expire which means that biosimilars can be produced that will work the same, but will not be as expensive.
Insulin is the oldest biologic drug although it wasn’t always characterized as a biologic. On March 23, 2020 insulin was officially moved to the biologic regulatory framework.
Biologic medications are large, complex molecules made from living cells or tissue. Insulin, Victoza® and Trulicity® are examples of biologic medications that help manage diabetes.
A list of other diseases treated by biologic drugs
- Various cancers.
- Rheumatoid arthritis (RA)
- Ankylosing spondylitis.
- Crohn’s disease.
- Ulcerative colitis.
- Multiple sclerosis (MS)
Cost of Biosimilars and Generic Drugs
Biosimilars tend to be less expensive than biologics because the original drug development has already happened and their path to FDA approval is shorter and cheaper. Some online retailers like GoodRx may offer discount coupons for non-branded products like biosimilars, which can help lower the cost as well.