Biosimilars in the US: Approvals and Market Outlook

By Patricia Van Arnum - DCAT Editorial Director

November 11, 2020

It has been 10 years since the Biologics Price Competition and Innovation Act (BPCIA) was signed into law, which authorized the regulatory pathway for biosimilars in the US. Since then, 28 biosimilars have been approved. What are leading products approved thus far, and what does the market hold?

Biosimilars and the US

A biosimilar is a biological product that is both highly similar to, and has "no clinically meaningful differences" from, an existing and already approved biologic medicine (often called a reference product). Biosimilars are FDA-approved for a subset or all of the same indications as their respective reference products. Biosimilar market penetration in the US has thus far been measured. As of July 2020, 28 biosimilars have been approved by the US Food and Drug Administration’s Center for Drug Evaluation and Research (see Table I at the end of the article). 

However, development and approvals of biosimilars have been accelerating in the US over the past two years, according to a recent report by the IQVIA Institute for Human Data Science, Biosimilars in the United States 2020–2024: Competition, Savings, and Sustainability. In its analysis, IQVIA reports that an additional 108 biosimilars are in development across 22 other molecules and will potentially reach the US market within the next 10 years, according to the analysis.

“Contrary to some predictions, biosimilars are not a failed concept; they are in fact becoming a growing part of affordable treatment options available to payers, physicians and patients,” said Murray Aitken, IQVIA Senior Vice President and Executive Director of the IQVIA Institute for Human Data Science, in commenting on the report. “It is our estimate that biosimilars could reach $80 billion in aggregate sales over the next five years, including $16 billion to $36 billion in 2024.”

In terms of market penetration, biosimilars have had mixed results although certain recently approved products show more promise. Recent launches of biosimilar bevacizumab (reference product, Roche’s Avastin), trastuzumab (reference product, Roche’s Herceptin), and rituximab (reference product, Roche’s and Biogen’s Rituxan) are set to reach nearly 60% volume share by the end of their second year on the market, which is significantly higher and faster than prior biosimilars, according to the IQVIA analysis.

Overall, however, biosimilar adoption in the US has been varied. “The growing willingness by stakeholders across the US to adopt biosimilars is confounded by an extreme heterogeneity across provider groups where biosimilar usage ranges from 0% to 100%,” according to the IQVIA analysis. “These differences reflect contracting approaches by manufacturers and providers, and prescriber willingness to adopt biosimilars, including the associated issues with changing patient treatment protocols. In some cases, the introduction of biosimilars has generated 2–4% incremental demand for the molecule as it represents a lower-cost option.

The IQVIA report estimates that savings enabled by the presence of biosimilars are modeled to exceed $100 billion in aggregate over the next five years although it points out that volume and price dynamics remain volatile and significant uncertainty remains. The report points out that price declines for biosimilars significantly vary but are in line with prior IQVIA assumptions of roughly 30% discounts. The report points out that higher discounts have occurred for many biosimilars, and an increase in the average discount is possible in the future.

Big Pharma and biosimilars

Unlike small-molecule generics, where there are often multiple generic companies providing a generic product, the biosimilar landscape is more limited, in part due to the complexity of the molecule itself and the requirement for clinical testing in biosimilar regulatory approval. Unlike small-molecule generics, biosimilars require some clinical testing before they can be approved, which creates an additional barrier of entry and cost for potential market biosimilar participants. In terms of companies in the biosimilars space, large pharmaceutical companies, often with existing innovative biologic portfolios, lead the marketing of biosimilars while the smaller companies that are developing biosimilars are likely to license products to the larger company for marketing, according to the IQVIA analysis. Currently, 13% of the biosimilar products in the pipeline are being developed by six large pharma companies; those with more than $10 billion global sales. The remaining 87% are being developed by 41 smaller companies with varying degrees of biologic or biosimilar development experience.

Table 1 (see end of article) highlights the biosimilar approvals in the US, which shows biosimilar approvals by Amgen, Pfizer, Novartis’ Sandoz, Merck & Co., and Boehringer Ingelheim, all with at least one biosimilar approval with generic-drug companies, Mylan and Teva Pharmaceuticals, also with approvals.

The pharmaceutical majors’ position in biosimilars is to develop products not part of their own innovative pipelines but to target other large-selling products from other companies. Amgen is developing a portfolio of 10 biosimilars, with four that are FDA-approved and the others in development. In December 2011, Amgen and Allergan (now part of AbbVie) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. Pfizer increased its position in biosimilars through its $17-billion acquisition of Hospira in 2015. Pfizer is merging its off-patent branded and generic established medicines business with Mylan, in a deal that is scheduled to close later this month (November 2020) to form a new company, Viatris. Pfizer's biosimilars business will remain part of Pfizer. 

Merck & Co. is planning to spin off its biosimilars business as part of a larger move, announced in February (February 2020) to spin off products from its Women’s Health, Legacy Brands, and Biosimilars businesses to form a new, yet-to-be-named, independent, publicly traded company. The spinoff is expected to be completed in the first half of 2021, subject to market and certain other conditions. The new company will have a position in biosimilars along with its partner, Samsung Bioepis, and focus on its current portfolio. This includes two immunology drugs, Renflexis (infliximab-abda), a biosimilar of Johnson & Johnson’s Remicade, an anti-inflammatory drug in multiple indications, and Brenzys (etanercept), a biosimilar of Amgen’s Enbrel, an anti-inflammatory drug, and an oncology drug, Ontruzant (trastuzumab-dttb), a biosimilar of Roche’s Herceptin. Samsung Bioepsis is a joint venture between Samsung BioLogics and Biogen.

Table I: Biosimilars Approved by the US Food and Drug Administration (as of July 9, 2020)
Originator Company/Reference Product Biosimilar Company Biosimilar FDA Approval Date
AbbVie’s Humira (adalimumab) Fujifilm Kyowa Kirin Biologics and Mylan Hulio (adalimumab-fkjp) July 2020
AbbVie’s Humira (adalimumab) Pfizer Abrilada (adalimumab-afzb) November 2019
AbbVie’s Humira (adalimumab) Samsung Bioepis and Merck & Co. Hadlima (adalimumab-bwwd) July 2019
AbbVie’s Humira (adalimumab) Novartis’ Sandoz Hyrimoz (adalimumab-adaz) October 2018
AbbVie’s Humira (adalimumab) Boehringer Ingelheim Cyltezo (adalimumab-adbm) August 2017
AbbVie’s Humira (adalimumab Amgen Amjevita (adalimumab -atto) September 2016
       
Amgen’s Enbrel (etanercept) Samsung Bioepis and Merck & Co. Eticovo (etanercept-ykro) April 2019
Amgen’s Enbrel (etanercept Novartis’ Sandoz Erelzi (etanercept-szzs) August 2016
       
Amgen’s Epogen (epoetin-alfa) Pfizer Retacrit (epoetin alfa-epbx) May 2018
       
Amgen’s Neulasta (pegfilgrastim) Pfizer Nyvepria (pegfilgrastim-apgf) June 2020
Amgen’s Neluasta (pegfilgrastim) Novartis’ Sandoz Ziextenzo (pegfilgrastim-bmez) November 2019
Amgen’s Neulasta (pegfilgrastim) Coherus Biosciences Udenyca (pegfilgrastim-cbqv) November 2018
Amgen’s Neulasta (pegfilgrastim Mylan Fulphila (pegfilgrastim-jmdb) June 2018
       
Amgen’s Neupogen (filgrastim) Pfizer Nivestym (filgrastim-aafi) July 2018
Amgen’s Neupogen (filgrastim) Novartis’ Sandoz Zarxio (Filgrastim-sndz) March 2015
       
Johnson & Johnson’s (Janssen) Remicade (infliximab) Amgen Avsola (infliximab-axxq) December 2019
Johnson & Johnson’s (Janssen) Remicade (infliximab) Pfizer Ixifi (infliximab-qbtx) December 2017
Johnson & Johnson’s (Janssen) Remicade (infliximab) Samsung Bioepis and Merck & Co. Renflexis (infliximab-abda) May 2017
Johnson & Johnson’s (Janssen) Remicade (infliximab) Pfizer Inflectra (infliximab-dyyb) April 2016
       
Roche’s Avastin (bevacizumab) Pfizer Zirabev (bevacizumab-bvzr) June 2019
Roche’s Avastin (bevacizumab) Amgen Mvasi (bevacizumab-awwb) September 2017
       
Roche’s Herceptin (trastuzumab) Amgen Kanjinti (trastuzumab-anns) June 2019
Roche’s Herceptin (trastuzumab) Pfizer Trazimera (trastuzumab-qyyp) March 2019
Roche’s Herceptin (trastuzumab) Samsung Bioepis and Merck & Co. Ontruzant (trastuzumab-dttb) January 2019
Roche’s Herceptin (trastuzumab) Celltrion and Teva Pharmaceuticals Herzuma (trastuzumab-pkrb) December 2018
Roche’s Herceptin (trastuzumab) Mylan Ogivri (trastuzumab-dkst) December 2017
       
Roche’s and Biogen’s Rituxan (rituximab) Pfizer Ruxience (rituximab-pvvr) July 2019
Roche’s and Biogen’s Rituxan (rituximab) Teva Pharmaceuticals Truxima (rituximab-abbs) November 2018
       

Hadlima (adalimumab), Eticovo (etanercept-ykro), and Ontruzant (trastuzumab-dttb) were developed by Samsung Bioepis and will be commercialized in the US by Merck & Co.

Roche and Biogen collaborate on Rituxan (rituximab) in the US and Roche markets MabThera (rituximab) in the rest of the world.

Inflectra (infliximab-dyyb) was originally developed by Hospira, which Pfizer acquired in 2015. Inflectra was approved by the FDA in April 2016. Pfizer also had its own biosimilar, Ixifi (infliximab-qbtx), which was approved by the FDA in December 2017.

Source: US Food and Drug Administration and company information.