Pharmaceutical Biotechnology Fundamentals and Applications

Over the past 30 years, the share of biotechnologically derived drug products in the arsenal of medicinal products has been growing steadily. These drug products include proteins, such as monoclonal antibodies, antibody fragments, endogenous or modified hormones, and growth factors, as well as antisense oligonucleotides, RNA, DNA preparations for gene therapy, and stem cell therapies. In 2017, 12 out of the 46 approved marketing authorizations for new molecular entities by the US Food and Drug Administration (FDA) were biotech products, mainly from the monoclonal antibody family (Mullard 2018). Drug products such as epoetin-α (Epogen®, Eprex®, Procrit®), interferon-α (Intron®A, Roferon®A) and interferon-β (Avonex®, Rebif®, Betaseron®), anti-TNF-α agents, etanercept (Enbrel®), infliximab (Remicade®), adalimumab (Humira®), bevacizumab (Avastin®), and trastuzumab (Herceptin®) are all examples of highly successful biotech drugs that have revolutionized the pharmacotherapy of previously unmet medical needs. And, last but not least, biotech drugs also have a major socioeconomic impact. In 2017, 7 of the 10 top selling drugs in the world were biotechnologically derived drug products, with sales varying between 5–16 billion US dollars, totaling 75 billion dollars. The revenues of biotechnology-based medication are annually growing at a 10% pace and will reach 300 billion US dollars in 2021, i.e., one third of the total global revenues for brand medicines in that year (IFPIA 2017).

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