Page 16 - Boca ViewPointe - May '23

Page 16, Viewpointe May 2023
A Look At The Biopharmaceutical Industry

By Harold Katz, R.Ph. tramadol); a suffix ending in -azolam places the drug in the
anti-anxiety family (alprazolam); a suffix ending in -alol
ViewPointe Readers identifies a blood pressure lowering entity (atenolol). The
have been aware of a flurry system may seem confusing to lay people, but medical people
of new pharmaceutical read these like a book and immediately identify the drug.
products advertised on TV and Furthermore, these non-proprietary names are submitted to
elsewhere. These new drugs the WHO (World Health Organization) and if approved, these
have several characteristics biopharmaceutical names are recognized in every country
in common: The names are in the world. No chance for confusion as has occurred with
difficult to pronounce, they some older generics.
are a triumph in biological We have entered a whole new world of pharmaceuticals.
manufacturing, there are no generic forms possible, and, It will be possible in the future to prescribe a medication
without exception, they are expensive. The foregoing is a drug name anywhere. Examples are: Blincyto, Tecenriq, and based on its structure and its compatibility with the
description of a biopharmaceutical. Tanzeum… not related to anything pharmaceutical. On the individual patient’s enzymes, DNA, and other factors. In
A good simple definition of a biopharmaceutical (or other hand, the non-proprietary names (generic names) are a few words, fit the drug to the patient. This, plus the age
biological medical product) is: “a pharmaceutical drug submitted to the USAN (the United States Adopted Name of biopharmaceuticals portends a bright future for patients,
product manufactured in, extracted from, or semi-synthesized Council) and their suffix (sometimes the prefix) identifies doctors, and the practice of medicine.
from a biologic source.” Included in this definition would the therapeutic category. For example: a suffix ending in
be: vaccines, blood components, and genetically engineered -adol would be in the category of pain relievers (example: Harold Katz R.Ph., Edgewater Estates 
therapeutic proteins, all from living cells.
The FDA (Food and Drug Administration) carefully
monitors this new family of drugs. It allows 12 years of
exclusivity before competitive items can be marketed. By
comparison, 20 years of exclusive marketing is granted for
regular pharmaceuticals made by chemical synthesis. In both
cases, most of the time allotted is consumed by research and
studies to prove safety and effectiveness.
Since there are no generic forms possible (scientists
cannot duplicate a living organism…yet), the FDA, for
competitive reasons, has allowed the development of
biosimilar drugs. A biosimilar drug is a “biologic product
approved by demonstrating it is highly similar to an FDA
approved biologic product, with no clinically meaningful
difference in safety and effectiveness.” Presumably, the
biosimilar will come to market at a competitive price
compared to the original, which is known as the reference
product. Lower prices in the marketplace would be most
desirable since some of these new entities have an estimated
cost to the patient well north of $200,000 annually. Both
Medicare and the insurance companies have voiced concerns
about future budgets.
These biopharmaceuticals are considered a triumph
in manufacturing when you consider these organisms can
be microscopic in size, they frequently must be dissected,
collected, and purified. A method has to be developed to
produce the active ingredient in large quantities to make

the drug available to many patients. Each step requires the BUYER? SELLER?
know-how of many scientific specialties. Call Joe Young
Concerning the brand names (proprietary names), they THIS IS THE MARKET YOU YOU NEED EXPOSURE &
are intentionally named not to be confused with any similar
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