By 2025, $112 billion of biologic medicines will lose exclusivity in the global market. Uptake of biosimilars will gain momentum, especially in the US, which has historically lagged compared to Europe. Which companies and biologics face biosimilar competition, and what is the near-term outlook for biosimilars?

Inside the numbers

The global biologic medicines market was valued at $320 billion in 2020 and accounts for almost one third of the global market for pharmaceuticals by value, according to recent analysis by the IQVIA Institute for Human Data Science. By 2025, $112 billion of biologic medicines will lose exclusivity in the global market. This figure has doubled since 2018 and is driven by the prospect of major losses of exclusivity, notably of adalimumab (reference product: AbbVie’s Humira) in the US. Between 2024 and 2029, approximately 100 biologic medicines are expected to lose exclusivity. Through 2025, the cumulative savings from biosimilars is projected to reach an estimated $285 billion on a global basis, according to IQVIA analysis.

To date (as of July 31, 2021), the US Food and Drug Administration (FDA) has approved 30 biosimilar products in the US (see Table I at end of article). Its most recent approval came last month (July 2021) with the approval of a biosimilar interchangeable product, Semglee (insulin glargine-yfgn), by Viatris and Biocon of Sanofi’s Lantus (insulin glargine), a long-acting insulin to treat Type 1 and Type 2 diabetes. The approval marked the first interchangeable biosimilar insulin product and is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus, according to information from the FDA.

The significance of the approval is that it was for an “interchangeable” product. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution,” much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state, according to information from the FDA.

Biosimilar approvals in the US reflect several key products with multiple companies having received approval. Unlike the small-molecule generics market, biosimilar players reflect some traditional generic companies, such as Teva and Viatris (formed from the 2020 merger of Mylan and Pfizer’s Upjohn, Pfizer’s generics and established medicines business, excluding Pfizer’s biosimilar business which Pfizer retained) as well as large bio/pharmaceutical companies with a position in biosimilars, such as Pfizer, Amgen, and Novartis through Sandoz. The biosimilar landscape also includes large companies partnered with other companies. This includes Samsung Bioepis, a joint venture between Biogen and Samsung Biologics, and a separate partnership between Samsung Bioepis and Merck & Co.

Key recent biosimilar product launches in the US are monoclonal antibodies for oncology and include those for bevacizumab (reference product: Roche’s Avastin), trastuzumab (reference product: Roche’s Herceptin) and rituximab (reference product: Roche’s/Biogen’s Rituxan).