Biotechnology is a relatively new sector with huge promise for advancement of disease therapies. Recent research on biosimilar, biobetter, and next-generation therapeutic antibodies has opened up whole new vistas for disease treatment approaches and may represent the future of biotechnology therapeutics.
Biosimilar antibodies are generic version of originator antibodies, as they have the same amino acid sequence but are made using diverse clones and manufacturing methods. As a result, there may be variances in glycosylation and other microvariations, such as charge variants, which can change quality, safety, and potency. In the United States, biosimilars are also referred to as follow-on biologics.
As with generics, biosimilar cost savings for healthcare systems and the consumer are expected to be significant. According to the RAND Corporation, biosimilars could save the U.S. health system close to $54 billion on biologics spending from 2017 to 2026.
Biobetter antibodies are antibodies that target the same validated epitope as a marketed antibody, but have been engineered to have improved properties, such as optimized glycosylation profiles to enhance effector functions, or an engineered Fc domain to increase the serum half-life. Such antibodies with controlled and optimized glycosylation have been obtained in glyco-engineered CHO cells or yeast strains. The cost of this treatment is expected to decrease because of lower cost of the products, less frequent administration regimens or lower dosages.
To date, biobetter developers have focused their attention on developing new products with improved formulations, greater in vitro or in vivo stability and longer circulatory half-lives. In the future, the largely untapped potential of biobetters to deliver enhanced drug performance by increasing the drug delivered to the desired anatomical location or target tissue at the desired quantities, while reducing off-target toxicity and adverse events, will be more widely explored.
Monoclonal antibodies (mAb) are emerging as one of the major classes of therapeutic agents in the treatment of many human diseases. However, the full potential of therapeutic antibodies has yet to be realized. With the advancement of antibody engineering technologies and further understanding of disease biology as well as antibody mechanism of action, next-generation antibodies, including bispecific antibodies, antibody-drug conjugates, and antibodies with modified Fc functions, are emerging as promising new generation therapeutics.
Therapeutic antibodies have high target specificity, lower systemic toxicity, longer half-life, and potentially higher barrier for biosimilar competition. The future growth of mAb based therapeutics is still strong. These new antibody formats or molecules are carefully designed and engineered to acquire special features, such as improved pharmacokinetics, increased selectivity, and enhanced efficacy. These new agents may have the potential to revolutionize both our thinking and practice in the efforts to research and develop next generation antibody-based therapeutics.
With pioneering achievements in biotechnology research and innovation, the practice of medicine has altered tremendously over the years, and millions of patients across the world have benefited from novel biotech therapies. Future biotechnology research will continue to provide exciting new discoveries to heal millions more people across the world as scientists seek to generate therapeutics that address enormous unmet needs.