Biosimilars: What They Are, How They Work, Low Drug Prices?
Biosimilars is a word you may have recently heard about, but do you really know what they are? Will they provide you with lower drug prices?
Biosimilar: What Is It?
A biosimilar is a biological drug that is not clinically different compared a regular drug in terms of safety, purity, and potency.
An example of an approved biosimilar is Amjevita, the first biosimilar approved for the blockbuster seller Humira. It is also used to treat rheumatoid arthritis and psoriasis, among many other uses.
However, an important distinction is that a biosimilar is not considered a “generic” in the same way that a traditional drug is determined to be a generic.
As with generics, biosimilar cost savings for healthcare systems and the consumer are expected to be significant.According to the RAND Corporation, biosimilars could save the U.S. health system close to $44 billion in the next ten years. More on this prediction, below.
Biosimilar: What is a Biologic?
If a biosimilar is a biologic, then what is a biologic?
Biological products can include a wide range of products including:
proteins, like monoclonal antibodies and cell signaling proteins.
Biological products come from a living organism, such as humans, animals, microorganisms or yeast. Clinically, they are used to treat patients with cancer, kidney diseases and autoimmune diseases, such as rheumatoid arthritis and Crohn’s disease.
For example, Enbrel or Humira are referred to as “large-molecule” drugs because they are larger and more complex in structure than small-molecule drugs.
These products are very expensive, often in the tens-of-thousands of dollars per year, due to costs necessary to develop them and to get FDA approval through the four clinical stages.
Biosimilars are similar because they do not have to be exact copies of the active ingredient, as with small-molecule drug generics.
In 2010, President Obama signed into law an abbreviated approval pathway for biologics to create competition, increase treatment options and reduce healthcare costs. Under that law, a biological product may be demonstrated to be “biosimilar” if data show that the product is “highly similar” to an already-approved biological product.
Biosimilars: Are They Really Saving Us Money On Prescriptions?
They’re meant to save money us money on drug prescriptions, improve the health care system, and lower drug company profits. But is this really happening?
This is a great theoretical concept, but a dud in real-life terms.
Why? Simple explanation. Biosimilars are cheaper versions of blockbuster drugs but can only be sold when the blockbusters lose their patent protection.
Conceptually, they are similar to generics but different from them in that biosimilars mimic biologic drugs. They are also crafted from living cells; whereas generics are made from chemicals.
This explains why biosimilars, haven’t taken off in the United States. The process of making a biological treatment is considerably more complicated than manufacturing a pill.
And, this complication hits a major snag when confronted by the patents that cover all origin and manufacturing facets of the original drug. Therefore, very few biosimilars actually come to market.
In fact, the way the game is played is very interesting.
Drug companies can file patents not just on biologics themselves but also on how they’re made, how they’re formulated, and how they’re administered.
That means the famed “patent cliff” that saw blockbuster pills rendered affordable in generic form-within days of losing their exclusivity, has never come from biosimilars. They really are too ‘similar’.
So unless and until the Congress passes laws that will lower drug prices, you can expect current prescription drug costs to continue going up.