Biosimilars Market Outlook: Uptake Gains Momentum in US

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). 

Table I: FDA-Approved Biosimilars (as of July 31, 2021)
Biosimilar name Approval Date Reference ProductBiosimilar Company
Semglee (insulin glargine-yfgn)July 2021Sanofi’s Lantus (Insulin glargineViatris and Biocon
Riabni (rituximab-arrx)December 2020Roche’s/Biogen’s Rituxan (rituximab)Amgen
Hulio (adalimumab-fkjp)July 2020AbbVie’s Humira (adalimumab)Viatris and Fujifilm Kyowa Kirin Biologics
Nyvepria (pegfilgrastim-apgf)June 2020Amgen’s Neulasta (pegfilgrastim)Pfizer
Avsola (infliximab-axxq)December 2019Johnson & Johnson’s Remicade (infliximabAmgen
Abrilada (adalimumab-afzb)November 2019AbbVie’s Humira (adalimumab)Pfizer
Ziextenzo (pegfilgrastim-bmez)November 2019Amgen’s Neulasta (pegfilgrastim)Novartis’ Sandoz
Hadlima (adalimumab-bwwd)July 2019AbbVie’s Humira (adalimumab)Samsung Bioepis
Ruxience (rituximab-pvvr)July 2019Roche’s/Biogen’s Rituxan (rituximab)Pfizer
Zirabev (bevacizumab-bvzr)June 2019Roche’s Avastin (bevacizumab)Pfizer
Kanjinti (trastuzumab-anns)June 2019Roche’s Herceptin (trastuzumab)Amgen
Eticovo (etanercept-ykro)April 2019Amgen’s Enbrel (etanercept)Samsung Bioepis
Trazimera (trastuzumab-qyyp)March 2019Roche’s Herceptin (trastuzumab)Pfizer
Ontruzant (trastuzumab-dttb)January 2019Roche’s Herceptin (trastuzumab)Samsung Bioepis and Merck & Co.
Herzuma (trastuzumab-pkrb)December 2018Roche’s Herceptin (trastuzumab)Teva Pharmaceuticals and Celltrion
Truxima (rituximab-abbs)November 2018Roche’s/Biogen’s Rituxan (rituximab)Celltrion
Udenyca (pegfilgrastim-cbqv)November 2018Amgen’s Neulasta (pegfilgrastim)Coherus Biosciences
Hyrimoz (adalimumab-adaz)October 2018AbbVie’s Humira (adalimumab)Novartis’ Sandoz
Nivestym (filgrastim-aafi)July 2018Amgen’s Neupogen (filgrastim)Pfizer
Fulphila (pegfilgrastim-jmdb)June 2018Amgen’s Neluasta (pegfilgrastim)Viatris
Retacrit (epoetin alfa-epbx)May 2018Amgen’s Epogen (epoetin-alfa)Pfizer
Ixifi (infliximab-qbtx)December 2017Johnson & Johnson’s Remicade (infliximab)Pfizer
Ogivri (trastuzumab-dkst)December 2017Roche’s Herceptin (trastuzumab)Viatris
Mvasi (bevacizumab-awwb)September 2017Roche’s Avastin (bevacizumab)Amgen
Cyltezo (adalimumab-adbm)August 2017AbbVie’s Humira (adalimumab)Boehringer Ingelheim
Renflexis (Infliximab-abda)May 2017Johnson & Johnson’s Remicade (infliximab)Samsung Bioepis
Amjevita (Adalimumab -atto)September 2016AbbVie’s Humira (adalimumabAmgen
Erelzi (Etanercept-szzs)August 2016Amgen’s Enbrel (etanercept)Novartis’ Sandoz
Inflectra (Infliximab-dyyb)April 2016Johnson & Johnson’s Remicade (infliximab)Celltrion
Zarxio (Filgrastim-sndz)March 2015Amgen’s Neupogen (filgrastim)Novartis’ Sandoz

Rituximab is jointly promoted as Rituxan by Biogen and Roche in the US. Roche is responsible for marketing rituximab as MabThera in the rest of the world.

Samsung Bioepis is a joint venturebetween Samsung Biologics and Biogen.

Viatris was formed in 2020 from the merger of Mylan and Pfizer’s Upjohn, Pfizer’s generics and established medicines business (excluding biosimilars).

Source: US Food and Drug Administration (FDA)

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