Biologics are large molecules made from genetically modified cells including humans, animals, and microorganisms such as bacteria or yeast. They are manufactured through biotechnology and take advantage of the recombinant DNA technology that involves genetically engineering of the cell. They are very sensitive to temperature and pH that makes them harder to characterize and produce on a large scale. Minor modifications can lead to changes in cell behavior, structure, stability or other quality aspects of the final product. Any of these differences will potentially affect the safety, efficacy and shelf life of the treatment.
Biologics include therapeutic proteins, DNA and monoclonal antibodies (mAbs), which are usually injected into the patient’s body due to their large size and sensitivity. They have been instrumental in treating serious diseases like inflammatory bowel disease (IBD), rheumatoid arthritis, psoriasis, hepatitis C, diabetes and various cancers.
The complexities of manufacturing biologics also apply to biosimilar. A biosimilar is developed to be highly similar to an approved/licensed reference biological product in terms of quality, safetty and potency. The defined process of a biosimilar is vital to ensure a high level of similarity to a reference product. The production of biosimilars is expected to increase as many of the patents for reference biological products coming to an end. The entry of biosimilars in the market will be greatly beneficial for consumers due to reduced costs for treatment of many life-threatening diseases.