Progress in biopharmaceutical development

Abstract

Since its introduction in 1982, biopharmaceutical drugs have revolutionized the treatment of a broad spectrum of diseases and are increasingly used in nearly all branches of medicine. In recent years, the biopharmaceuticals market has developed much faster than the market for all drugs and is believed to have great potential for further dynamic growth because of the tremendous demand for these drugs. Biobetters, which contain altered active pharmaceutical ingredients with enhanced efficacy, will play an important role in the development of biopharmaceuticals. Another significant group of biopharmaceuticals are biosimilars. Their introduction in the European Union and, recently, the Unites States markets will reduce the costs of biopharmaceutical treatment. This review highlights recent progress in the field of biopharmaceutical development and issues concerning the registration of innovative biopharmaceuticals and biosimilars. The leading class of biopharmaceuticals, the current biopharmaceuticals market, and forecasts are also discussed.

Keywords: biobetter; biopharmaceutical; biosimilar; drug market; monoclonal antibodies; recombinant vaccines.

Figure 1

Dates of patent expiry for the 10 best‐selling biopharmaceuticals in 2016. * Data not available.

Figure 2

Sales (US$ billion) of the five best‐selling vaccines in 2015. Prepared based on the data published by EvaluatePharma 2016 136.

Figure 3

The shares of recombinant proteins and mAbs in the world market of therapeutic proteins sales for 2016. Prepared based on the data published by La Merie in 2017 139.

Figure 4

Sales (US$ billion) of the 10 best‐selling biopharmaceuticals in 2016. Prepared based on the data published by La Merie in 2017 139.

Figure 5

Biosimilars and reference biopharmaceuticals development timeline 142, 143.