How Are Biological Medicines Different from Other Medications?

Small-molecule medicines are the most familiar type of medicine compounds, typically contained in a pill, tablet, or capsule.1 Examples range from analgesics and other pain relievers to antibiotics, antidepressants, and antihypertensives. These medicines are considered small molecules because their active ingredient is small in size and chemical structure.2

Biological medicines are complex products that are derived from living organisms or organic substances and include therapeutic proteins, DNA vaccines, monoclonal antibodies, and related products used for treating certain diseases. They are large molecules and are far more complex than small-molecule medicines.2-5

Click here to find out why the process of creating biological medicines matters.

Next: Why the Process Matters

See the high level of precision involved in creating a consistent biological product each time.

View the intricacies of manufacturing a biological medicine
Read a list of biologics questions answered by Dr. John Petricciani, M.D., an expert in biological medicines.

Expert Opinion

with Dr. Petricciani

This technology offers additional options for some of the most grievous and costly medical conditions.

Read more from Dr. Petricciani
References
  1. Mager DE, Ramanathan M. Preclinical pharmacokinetics. In: Gad SC, ed. Handbook of Pharmaceutical Biotechnology. Hoboken, NJ: John Wiley & Sons; 2007:253-278.
  2. Schellekens H. Biosimilar therapeutics—what do we need to consider? NDT Plus. 2009;2(suppl 1):i27-i36.
  3. Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin. 2012;28(6):1053-1058.
  4. Zhang J. Mammalian cell culture for biopharmaceutical production. In: Baltz RH, Davies JE, Demain AL, eds. Manual of Industrial Microbiology and Biotechnology, Third Edition. Washington, DC: American Society of Microbiology; 2010:157-178.
  5. Revers L, Furczon E. An introduction to biologics and biosimilars. Part I: biologics: what are they and where do they come from? Can Pharm J (Ott). 2010;143(3):134-139.
  6. Sekhon BS, Saluja V. Biosimilars: an overview. Biosimilars. 2011;1(1):1-11.
  7. Webster C, Copmann T, Garnick R, et al. Biologics: can there be abbreviated applications, generics, or follow-on products? Biopharm Int. 2003(July):28-37. http://www.biopharminternational.com/biopharm/article/articleDetail.hsp?id=73785&sk=&datepageID=2 Accessed December 4, 2012.
  8. Declerck PJ. Biologicals and biosimilars: a review of the science and its implications. GaBI J. 2012;1(1):13-16.
  9. Wurm FM. Production of recombinant protein therapeutics in cultivated mammalian cells. Nat Biotechnol. 2004;22(11):1393-1398.
  10. Palomares LA, Estrada-Mondaca S, Ramirez OT. Production of recombinant proteins: challenges and solutions. In: Balbas P, Lorence A, eds. Methods in Molecular Biology, Vol. 267: Recombinant Gene Expression: Reviews and Protocols, Second Edition. Totowa, NJ: Humana Press Inc.; 2004:15-51.
  11. Kuhlmann M, Covic A. The protein science of biosimilars. Nephrol Dial Transplant. 2006;21(suppl 5):v4-v8.