Robust research and development activities for development of novel oral biologics

Key players are involved in extensive research and development of novel oral biologics for various conditions

In February 2019, researchers at Massachusetts Institute of Technology (MIT) developed a drug capsule with the potential to deliver an oral insulin named SOMA capsule, thereby replacing (or eliminating) the need to administer insulin via injections multiple times a day for patients with type 1 diabetes. The researchers stated that the drugs is currently under preclinical studies and is expected to enter clinical trials by 2022.

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The research was funded by Novo Nordisk, the National Institutes of Health, a National Science Foundation Graduate Research Fellowship, Brigham and Women’s Hospital, a Viking Olaf Bjork Research Scholarship, and the MIT Undergraduate Research Opportunities Program.

Such robust research and development activities by key players is expected to create a conducive environment and support global oral biologics market growth over the forecast period.

According to Labiotech.eu, 2018, around half of the top 100 drug sales will be biologics by 2022. Moreover, an estimated 2,700 biologics are currently in development, which means they can create a conducive biologics market post approval. However, the biological drugs are administered parentally, which can result in high treatment costs and lower adherence rates.

According to the research conducted by Rani Therapeutics in 2018, around 62% patients and 86% physicians reported that patients either skip their injection or consistently fail to inject the drug as prescribed. The research further stated that around 70% rheumatologists and 92% gastroenterologists believe that availability of pills would significantly increase patient compliance rates.

Thus, the availability of biologics in the form of oral pills is expected to increase compliance rate and patient comfort, which can significantly improve the patients’ health by changing the course of the disease and preventing further complications.

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CBER encourages manufacturers to use appropriate standards in the development of medical products. The use of appropriate standards can facilitate product development and provide a more efficient evaluation of regulatory submissions, including investigational new drug applications (INDs), biologics license applications (BLAs), new drug applications (NDAs), investigational device exemptions (IDEs), premarket approval applications, and premarket notifications, supplements, and amendments.

Key players operating in the global oral biologics market include Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, Inc., Rani Therapeutics, Entera Bio Ltd., Allergan plc, Emisphere Technologies, Inc., Enteris BioPharma, Inc., Chiasma, Inc., and Allena Pharmaceuticals, Inc.

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