Less than half a century ago, the pharmaceutical market was dominated by small molecule drugs. However, owing to concerns, such as off target toxicity and low specificity, associated with chemical moieties, and the need to shift from the one-size-fits-all approach to personalized medicine, a better class of pharmacological interventions was required. The first biologic drug, humanized insulin, was approved in 1982; over time, this class of target specific therapeutics have revolutionized the healthcare industry. Briefly, biologics offer several benefits, including target specificity, better therapeutic efficacy and, consequently, favorable safety profiles compared to conventional chemical-based drugs. Moreover, these molecules have also demonstrated the ability to access elusive biological targets and treat diseases that were previously considered undruggable.
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Presently, biologics represent the fastest growing product segment within the global pharmaceutical industry. In fact, as of September 2020, over 430 biological interventions were approved for the treatment of various disease indications in the US and Europe. Given the advantages they offer, biologics are in high demand for the treatment of different disease indications. It is a well-known fact that antibodies emerged as the major therapeutic breakthroughs and have seen significant success in the past two decades. There are other vast opportunities for biologics in the foreseeable future. This segment of healthcare industry is in the midst of numerous innovations; examples include antibody drug conjugates, immunotherapies, bispecific antibodies, combination therapeutics, and gene and cell therapies. These developments have set the stage for significant disruption, creating more therapeutic targets and, ultimately, taking personalized healthcare to new and astounding heights. Since 2015, six orally administrable drugs, manufactured using the continuous technique, have been approved by the FDA; these are TRIKAFTA® (Vertex Pharmaceuticals, 2019), DAURISMO™ (Pfizer, 2018), SYMDEKO® (Vertex Pharmaceuticals, 2018), VERZENIO® (Eli Lilly, 2017), PREZISTA® (Johnson & Johnson, 2016) and ORKAMBI® (Vertex Pharmaceuticals, 2015).[1], [2],[3], [4]
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Based on the active substances used, therapeutics can be categorized into two main segments, namely small molecules and biologics, that are currently available / being developed by players engaged in the pharmaceutical industry.
Since biologics are essentially structural analogues of various biomolecules found in the human body, they have highly specific mechanisms of action and fewer side effects, as compared to the conventional pharmacological molecules (mostly small molecules).
As a result, biologics are thought to possess the potential to target and eradicate the root cause of diseases at a cellular / genetic level.
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