The separation between what is a biotechnology company and what is a pharmaceutical manufacturer has become less and less distinct. What is the difference between pharma and biotech? Why are we starting to use those terms interchangeably or even merging them in the term biopharmaceuticals?
Biotechnology therapy or biologics is the applied knowledge of biology. This research seeks to duplicate or change the function of a living cell so it will work in a more predictable and controllable way. This work is often referred to as large molecule research and is manufactured in living organisms like bacteria, yeast or mammalian cells.
Pharmaceuticals are small molecule or synthetic drugs that are produced through chemical synthesis. These chemical compounds are easier to manufacture and easier to characterize because they tend to be simpler and more stable than biologics.
Biologics are starting to represent a larger portion of companies’ portfolios and Alacrita.com reports that this is expected to continue to grow for these reasons:
- Speed! A small molecule has to be discovered and optimized which historically takes an average of 5.5 years from target to a drug ready for Phase 1 clinical trials. Biologics can be developed much more quickly.
- Higher Rate of Success. Recent studies show that due to the higher target specificity and lower off-target effects, biologics might have a higher rate of success than small molecules. The likelihood of success from phase 1 to approval was twice the rate in biologics as in small molecules according to a study published in Translational Medicine.
- The specificity of biologics means they can have a better side effect profile. It is hard to make a specific small molecule which means too many small molecules are “dirty” or hit too many targets in the body, leading to unwanted “off-target” side effects.
- Biologics can hit multiple targets. They can be engineered to be bi- or tri-specific, meaning they bind to two or three targets.
- Franchise Life. The U.S. patent term is twenty years. Small molecules can be granted five years of additional exclusivity but biologics can get twelve years. Small molecule drugs are also much more vulnerable to generic competition while the size and complexity of a biologic is much harder to copy exactly.
Is there a downside to biotech products? Drug delivery is easier for small molecules. Traditional pharma drugs can be delivered orally while biologics are usually injected. Also, generics of biologics, biosimilars, are not as accepted by patients and doctors. The name itself calls into question its effectiveness. The good news is this means the sales of the original biologic decline at a slower rate.
As traditional big pharma companies develop biologics the line between the definition of a pharma and biotech company is blurring. Drug makers are starting to refer to themselves as biopharmaceutical companies to reflect their development of both small and large molecule drugs.
Interested in a career in biopharmaceuticals? Contact Smith Hanley Associates’ Pharmaceutical Sales Executive Recruiter, Nancy Ragonese at nragonese@smithhanley.com.
