The state of biosimilars in the United States


Mario DiPaola, Epic Pharma Consulting, Mansfield BioIncubator
241 Francis Avenue, MA, USA, 02048

Over the past decade, there has been a highly focused effort by US regulators in developing a pathway for the approval of biosimilars. Meanwhile, many small and large pharma/biotech companies have actively engaged in the development of many biosimilar products.

Briefly, a biosimilar is a biological product that is ‘highly similar’ to an existing FDA-approved reference product, such that it has ‘no clinically meaningful differences’ in comparison to the reference product with respect to product safety, purity and potency [1]. Furthermore, a biosimilar can be interchangeable with the reference product only if the biosimilar developer can demonstrate that the biosimilar generates the same clinical results as the reference product in any patient and that it can be substituted with the reference drug with no added risks based on safety and clinical efficacy [1].

Since the passage of the Biologics Price Competition and Innovation Act (BPCI Act) in 2009, 29 biosimilars covering nine biologics have received approval by the FDA. However, due to patent litigations of the approved biosimilars, only 20 have been launched so far. A list of the approved biosimilars and launch dates are provided in Table 1.

Table 1: FDA-approved biosimilars [2].

No. Biosimilar product Company Sponsor and /reference product Approval date Launch date
1 Zarxio® (filgrastim-sndz) Sandoz (Holzkirchen, Germany) Amgen Neupogen® 3/6/2015 September 2015
2 Inflectra®         (infliximab-dyyb) Celtrion (Incheon, South Korea)/Pfizer (NY, USA) Janssen Remicade® 4/5/2016 November 2016
3 Erelzi® (etanercept-szzs) Sandoz Amgen        Enbrel® 8/30/2016 NA
4 Amjevita® (adalimumab-atto) Amgen (CA, USA) AbbVie         Humira® 9/23/2016 2023a
5 Renflexis® (infliximab-abda) Samsung Bioepis (Incheon, South Korea) Janssen Remicade® 4/21/2017 July 2071a
6 CyltezoTM (adalimumab-adbm) Boehringer Ingelheim (Rhein, Germany) AbbVie      Humira® 8/25/2017 2023a
7 MvasiTM (bevacizumab-awwb) Amgen/Allergan (Dublin, Ireland) Genentech/Roche Avastin® 9/14/2017 July 2019
8 Ogivri®     (trastuzumab-dkst) Mylan (PA, USA)/Biocon (Bengaluru, India) Genentech/Roche Herceptin® 12/01/2017 December 2019
9 Ixifi®                  (infliximab-qbtx) Pfizer Janssen Remicade® 12/13/2017 NA
10 Retacrit® (epoetin-alfa-epbx) Pfizer Jenssen     Procrit® 5/15/2018 October 2018
11 FulphilaTM  (pegfilgrastim-jmdb) Mylan/Biocon Amgen   Neulasta® 6/4/2018 July 2018
12 NivestymTM (filgrastim-aafi) Pfizer Amgen   Neupogen® 7/20/2018 October 2018
13 HyrimozTM (adalimumab-adaz) Sandoz AbbVie     Humira® 10/30/2018 2023a
14 UdenycaTM (pegfilgrastim-cbqv) Coherus BioSciences (CA, USA) Amgen   Neulasta® 12/2/2018 January 2019
15 TruximaTM  (rituximab-abbs) Celltrion (Incheon, South Korea)/Teva (Petah Tikva, Israel) Biogen/GenentechRituxan® 11/28/2018 November 2019
16 HerzumaTM (trastuzumab-pkrb) Celltrion/Teva Genentech/Roche Herceptin® 12/14/2018 March 2020
17 OntruzantTM (trastuzumab-dttb) Samsung Bioepis Genentech/Roche Herceptin® 1/18/2019 April 2020
18 TrazimeraTM (trastuzumab-dttb) Pfizer Genentech/Roche Herceptin® 3/11/2019 February 2020
19 EticovoTM (etanercept-ykro) Samsung Bioepis Amgen        Enbrel® 4/25/2019 NA
20 KanjintiTM (trastuzumab-dttb) Amgen Genentech/Roche Herceptin® 6/13/2019 July 2019
21 Zirabev


Pfizer Genentech/Roche Avastin® 07/01/2019 December 2019
22 RuxienceTM  (rituximab-pvvr) Pfizer Biogen/Genentech Rituxan® 7/23/2019 January 2020
23 HadlimaTM (adalimumab-bwwd) Samsung Bioepis AbbVie      Humira® 7/23/2019 2023a
24 ZiextenzoTM  (pegfilgrastim-bmez) Sandoz Amgen   Neulasta® 11/4/2019 November 2019
25 AbriladaTM (adalimumab-afzb) Pfizer AbbVie      Humira® 11/15/2019 2023a
26 AvsolaTM         (infliximab-axxq) Amgen Janssen Remicade® 12/6/2019 July 2020
27 NyvepriaTM  (pegfilgrastim-apgf) Pfizer Amgen   Neulasta® 6/10/2020 NA
28 HulioTM  (adalimumab-fkjp) Mylan AbbVie      Humira® 7/6/2020 2023a
29 RiabniTM     (rituximab-arrx) Amgen Biogen/Genentech Rituxan® 12/17/2020 January 2021

The development of biosimilars presents numerous challenges in comparison to generic drugs. Among these, the more significant ones include:

  • Cost
  • Development time
  • Competition
  • Legal challenges
  • Interchangeability
  • Acceptance market entry (adoption)

As of 2021, it is anticipated that the cost for developing a biosimilar will range anywhere between USD$130 million up to USD$260 million. Even more challenging is the time that it takes to bring a biosimilar to market, which ranges between 8–10 years. Legal challenges from product innovators also present a sizeable barrier to biosimilar developers, as the innovators have mounted major legal challenges through patent protection strategies, thus delaying for as long as possible the introduction of any biosimilars against their products. Even after approval, a biosimilar will face competition not only from the reference product, but also from other biosimilars approved against the same original product. For example, there are already six approved biosimilars ready to be launched by 2023 against Humira, although it is important to note that the Humira franchise is quite large based on reported product revenues of USD$21 billion in 2020. Thus, any biosimilar gains in market share for adalimumab will still result in substantial revenues. Other challenges that are significant but potentially surmountable over time are the issues of product interchangeability, which is currently not in place for any of the presently approved biosimilars. There is also the challenge of patient and physician acceptance of biosimilars. Such acceptance has been rather slow due to a combination of some misinformation by product originators and an overall lack of education on the merits and benefits of biosimilars.

Among the launched biosimilars, those that have captured at least 10% of the market share are listed in Table 2.

Table 2: biosimilars with more than 10% of market share [3].

Company Biosimilar Launch date
Amgen Kanjinti July 2019
Amgen Mvasi July 2019
Coherus (CA, USA) Udenyca January 2019
Pfizer Retacrit October 2018
Sandoz Zarxio September 2015
Teva/Celltrion Truxima November 2019

Of these, Zarxio has probably become the most commercially successful biosimilar based on market penetration, accounting for nearly 50% of all units of short-term filgrastim dispensed and resulting in savings of approximately USD$500 million to the US healthcare system in just a few years. Furthermore, the increased availability and utilization of biosimilars is projected to save up to USD$100 billion in drug costs over the next 5 years [4].

The recent success of several biosimilars in market penetration has provided a number of useful lessons that should be quite helpful with the launch of newly upcoming biosimilars. First, it is very important that the development of a launch strategy be conducted well in advance of the actual launch date. Second, it is necessary to engage healthcare providers in extensive and comprehensive education prior to product launch. Third, just as importantly, is the utilization of all available advocacy efforts to ensure a successful product launch.

To conclude, while 2020 has positively reshaped the biosimilar landscape, much remains to be done to ensure that biosimilars gain a wider acceptance within the US market and result in the projected and highly anticipated cost savings to the US healthcare system.


[1] The Patient Protection and Affordable Care Act. Senate and House of Representatives of the United States of America in Congress, MD, USA (2010);

[2] Biosimilar product information. US Food and Drug Administration, MD, USA (2020);

[3] Fein AJ. The booming biosimilar market of 2020. Drug Channels. (2020);

[4] Biosimilars in the United Sates 2020–2024: competition, savings and sustainability. IQVIA Institute, NC, USA (2020);

The opinions expressed in this feature are those of the author and do not necessarily reflect the views of Bioanalysis Zone or Future Science Group.