Biopharmaceutics and Biologic Drugs

The global prescription drug market is expected to grow by 6% to reach nearly USD 1.05 trillion by 2022. Th e top 20 drugs are manufactured by 14 companies and account for a total 10% of global prescription drug market in 2016. Th e total revenue generated by top 20 products was estimated to be USD 0.128 trillion. Biologic drugs are cost eff ective opportunity for patients in the area of oncology, diabetes, infl ammatory disorders, Autoimmune diseases, cardiovascular diseases and represent a total market value of more than $50 billion. Th ere are 150 marketed biologic products worldwide, with almost 500 products under development. About 21 important biologics will loose patent protection by the year 2019. Th e biopharmaceuticals show much greater effi cacy and effi ciency when compared to conventional pharmaceuticals. Th e use of biopharmaceuticals is continuously increasing and has resulted in a huge market demand. Biological drug products including Biosimilars, are larger in size and more complex than conventional small molecule drugs and the majority of these originate from living organisms. During the product development phase, some of the process changes are inevitable such as Cell line change, Critical Raw Material change, Primary packaging components change, Scale up/ down, Process parameter change, Formulation, Presentation, Device and Form Change Site Change or Critical Equipment change. Multiple complex manufacturing processes involved in biologics drug product development may signifi cantly aff ect the product quality attributes, product development process and the product safety and/or effi cacy. Th ese may also aff ect the other quality attributes such as physical, chemical, biological, or microbiological property of the biologic drug product. Th ere are multiple challenges at every stage of development of high quality biologics drug products. Th ese include the initial clone development, clone expression, product development, processing, purifi cation, characterization, post translation modifi cations, sensitive bioanalytical methods and stringent regulatory expectations. Similarly, there are several challenges in the clinical development phase also. Th ese include Study Indication, Study Design, reference product, regulatory approvals, patient recruitment, Inclusion and Exclusion Criteria,

Statistical consideration, Immunogenicity, Safety assessment and Post marketing study requirement. Th e advancement in the technology and availability of scientifi c approaches have helped to a great extent in eff ectively combating the challenges andkeep the biologics drug development process at a rapid pace. Th e presentation on challenges in developing Biologics and Biosimilars gives an overview of scope for Biologics and Biosimilars drugs, various challenges and methods to overcome many of these challenges.