As part of our Ask the Experts feature, we explore some of the reasons why the field of biologics has witnessed such significant growth in recent years.
Why has the scientific community increased its focus on biologics over the last decade?
Chad Christianson (Alturas Analytics)
The revenue potential of bringing a biologic to market is much greater than most small molecule products. One reason for this phenomenon is the difficulty in getting approval for a biosimilar (generic product) once the patent expires. Although biologics make up only a small fraction of the total number of pharmaceutical products prescribed, biologics represent nearly all of the growth in spending. Additionally, the majority of the top 10 selling drugs on the market are biologics. The number one selling drug in the world over the last several years is the biologic Humira.
Matthew Ewles (Covance)
The focus on biologics has increased as our understanding and technology has increased to make this possible. The surges forward in our understanding of human genetics, the human genome project, the discovery of RNAi in the late 1990s and the later identification of its therapeutic potential have all resulted in the development of oligonucleotide therapeutics we are still seeing today. The advances in protein science and bioinformatics have allowed increasingly novel uses of proteins to enhance drug pharmacokinetics, targeting or efficacy. More novel molecules, such as antibody-drug conjugates can now be synthesized and characterized thanks to advances in analytics. Finally, our increasing understanding of disease on a molecular level enables us to develop increasingly targeted therapies, which is where biologics have the upper hand over traditional small molecules.
Wenying Jian (Janssen Research & Development)
Biologics provide unique advantages over small molecules for a number of reasons: (1) Protein therapeutics are typically highly specific with strong potency and therefore can provide very effective treatment; (2) Because of their high specificity, biologics elicit less off-target adverse effects and are usually well tolerated; (3) Successful rate of clinical development and regulatory approval speed of biologics are typically higher than that of small molecules; (4) Because of the complex forms and functions of proteins, inventors can usually obtain far-reaching patent protection for protein therapeutics; (5) Most importantly, advancement of bioengineering and molecular-targeting techniques has enabled the development of new generations of therapeutic biologics with unique properties that cannot be achieved by a simple small molecule approach. Some of examples of this include bi- or multi- specific antibodies, half-life extended biologics and antibody- or protein-drug conjugates for targeted delivery of cytotoxins.
Carsten Krantz (Novartis)
Biologics drugs are among the most fast-growing therapeutics in industry. This is mainly due to their very high selectivity to the target with virtually no off-target effects and thus fewer adverse events . Biologics have very high affinity for their targets and combined with half-live extension properties they can provide sustained responses at low doses.
 Leader B, Baca QJ and Golan DE. (2008). Protein therapeutics: a summary and pharmacological classification. Nat. Rev. Drug Discov.7, 21–39 (2008).
Keeley Murphy (Thermo Fisher Scientific)
Today’s biologic research efforts present an opportunity to provide effective treatments to complex diseases that were difficult to even imagine not too long ago. Over the past decade advances in analytical technology along with an increase in the overall body of knowledge within the drug development community have taken biologic research from a specialized or niche endeavor to a major part of every pharmaceutical innovator’s portfolio. Additionally, updates to regulatory guidance and acceptance frameworks have helped provide a roadmap for research efforts, helping to mitigate risk and reduce uncertainty as new projects and innovative initiatives are explored.
The opinions expressed in this feature are those of the authors and do not necessarily reflect the views of Bioanalysis Zone or Future Science Group.