Biosimilar: Expansion of pharmaceutical industry

  • February 16, 2023
  • 2 mins read

Innovations of new drugs in the pharmaceutical industry, like biosimilars, are opening new opportunities for the pharmaceutical industry and a wide spectrum of treatment options for patients.

The boom of biosimilars in oncology began with the approval of the EMA’s first antineoplastic biosimilar, Medice Arzneimittel Pütter’s Abseamed (epoetin alfa), in 2007. Oncology biosimilars account for the largest proportion of biosimilar therapeutics in the pharma market. To date, the EMA has approved 88 biosimilars, with 34 of those within oncology. Recently, the FDA approved 39 biosimilars, with 22 falling under oncology.

A “biosimilar” is a biological similar to, or nearly identical to, an existing FDA-approved reference biological. The significantly inexpensive prices of biosimilars make them an appealing substitute for branded biologics. Due to this, biosimilars increase patients’ access to advanced treatments, leading to improved clinical outcomes. Although biosimilars are highly represented in oncology, their presence is felt less in other treatment areas. However, data collated from GlobalData’s Trial Intelligence platform suggests a decline in the proportion of biosimilar trials started for oncology and an increase in trials among 7 of the top 10 biosimilar therapy areas from 2021 to 2022.

As the FDA’s first biosimilar drug was approved in 2015, biosimilars have generated more than $13 million in savings for patients and the US healthcare system. As biosimilars in other therapy areas gather more momentum, they will contribute to meeting the demand for additional treatment options. Moreover, GlobalData forecasts that expanding biosimilars outside of oncology indications will continue to drive growth in the biopharmaceutical industry due to an increased need for outsourced manufacturing. As per McKinsey’s Biosimilar market model, this growth is set to reach $60 billion by the end of the decade.