Introduction

The type of pharmaceutical drug being referenced throughout this discussion goes by many different names. These terms include “biopharmaceuticals”, “biological medical products”, or simply a “biologic”.

Some regulatory agencies distinguish between (1) medicines that are extracted “directly” from biological sources, such as blood components and vaccines; and (2) medicines that are based on engineered macromolecular products, such as nucleic acid-based drugs.

The European Medicines Agency (the equivalent of the US FDA) uses the term “advanced therapy medicinal products” for most new medicines that are based on “genes, cells or tissue engineering.”

There will be an attempt to use the term “biologic(s)” for all such drugs throughout the remainder of this discussion. Any generic version of a biologic drug is called a “biosimilar,” and this term will be used below.

It is widely anticipated that the market for generic versions of biologics will expand at a rapid rate, and will be profitable for the leaders in this future market.

A brief history of biologics is helpful to understanding the recent development of the biosimilar market. Next, the very recent history of the biosimilar market will be presented. Following that is a discussion of the major companies in the biosimilar pharmaceutical economy; and lastly, there will be a conclusion and recommendation about a possible SDG.

Brief History of Biologics

These types of medicines actually were the first kinds of medicines used by almost all cultures prior to the advent of “modern” medicines. Peoples have been using potions, extracts, concoctions, elixirs, plants, etc. for centuries; and these types of medicines are still in use in certain regions of the world.

In modern times, most biologics are produced by means of a biological process involving recombinant DNA technology. This is a relatively well-understood platform for creating “new” substances.

The first such new substance was created in 1982: a biosynthetic “human” insulin. This was developed by a company called Genetech, now a division of Roche Holdings.

Most of the biopharmaceutical medicines created since the 80’s are based on genes, cells or tissue engineering using recombinant DNA technology, as noted above. These medicines have been close to miracles in treating a broad range of diseases.

However, in addition to the great advances in treating illnesses, these drugs have raised other complex issues, including high costs, variable regulatory development, new approval processes for their use, and ethical issues associated with their use in certain situations.

Another type of modern biologic are monoclonal antibodies that bind to specific proteins or cells within the body, and produce a natural immune response.

That's it for part 1! Part 2 will be posted tomorrow and will continue this analysis of the "Biosimilar" Pharmaceutical Markets! Stay tuned and don't forget to answer the QOTD!

---

Question of the Day:

Have you heard of Biologics before reading this post? What did or didn't you know about them before reading this post?

Thank you for reading!