Biologics: The New Era of Medicine

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Biologics are proteins that are sourced from living organisms. Unlike the production of conventional drugs, which involves use of chemical libraries of synthetic small molecules, biologic drugs are manufactured using living cells. Major pharmaceutical companies are focused on developing biologic drugs for the treatment of various diseases. In December 2019, MediWound Ltd., a biotechnology company focused on R&D in burn and chronic wound management, initiated Phase 2 clinical study of EscharEx, a topical biologic drug for the treatment of venous leg ulcers. Biologics have also found application in the treatment of various types of cancer. Immune checkpoint inhibitors, immune cell therapy that includes tumor-infiltrating lymphocytes and CAR T-cell therapy, therapeutic antibodies, and immune-modulating agents halt the immune system from damaging normal cells.

Conventional pharmaceuticals can be mass-produced in large factories. However, manufacturing of biologic drugs involves complicated processes. This in turn increases the cost of biologics. Ilaris (canakinumab), an injectable human anti-interleukin-1β monoclonal antibody, may lead to an annual expenditure of US$ 380 thousands to US$ 460 thousands. It is used for the treatment of periodic fever syndromes, a group of rare autoinflammatory diseases. The demand for specialty drugs is high in developed economies and with high healthcare expenditure, the pricy biologics are expected to retain a significant market share. The U.S. healthcare expenditure is expected to reach nearly US$ 6.0 trillion by 2027, as per The Centers for Medicare & Medicaid Services. Biologics also offer several advantages over conventional drugs. Biologics are effective in the treatment of rare disorders and are capable of targeting molecular processes, which conventional drugs often fail to target. In April 2020, Innovent Biologics, Inc. received approval for Pemazyre (pemigatinib), an orally bioavailable inhibitor of the fibroblast growth factor receptor, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma.

Several biologics are expected to lose patient in the near future. This is expected to favor growth of biosimilars. However, several startups are also focused on raising funds for R&D of new biologics. In April 2020, i2O Therapeutics, a Harvard-launched biotech company developing a platform for oral delivery of injectable biological drugs, raised US$ 4 million in seed funding led by Sanofi Ventures and JDRF T1D Fund. Moreover, pharmaceutical companies are integrating their expertise in development of novel biologic drugs. In March 2020, I-Mab, a clinical stage biopharmaceutical company, partnered with Kalbe Genexine Biologics, a joint venture of Kalbe Farma Tbk, and Genexine, Inc. According to the partnership, KG Bio will receive a right of first negotiation for an exclusive license for the commercialization of two I-Mab discovered product candidates: TJD5, an anti-CD73 antibody in Phase 1 development for advanced solid tumors, and an I-Mab product candidate.

The U.S. Food and Drug Administration is also focused on approving novel biologics. In June 2019, Ethicon, part of the Johnson & Johnson Medical Devices Companies, received a 510(k) clearance from the FDA for its Vistaseal applicators, which spray a biological sealant to stem moderate bleeding during open or laparoscopic surgical procedures. Such scenarios are expected to be boost the demand for biologic drugs in the near future.

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