Approval and launch dates for US biosimilars

To date (7 May 2021), the US Food and Drug Administration (FDA) has approved 29 biosimilars, plus four follow-on biologicals [1]. The pipeline for biosimilars continues to grow, however, of the 29 biosimilars approved, only 20 have so far been launched [2].

In fact, biosimilars currently make up only 2.3% of the US biologicals marketplace. Currently, 90% of global biosimilars sales take place in Europe, despite 60% of overall biologicals sales occurring in the US [3].

Reasons for delays in launching biosimilars and the sluggish biosimilars market in the US may include anti-competitive behaviours and other market and regulatory dynamics that currently discourage market uptake of biosimilars in the US [3]. However, other issues include the use of payment policies that disincentivize use of biosimilars and lack of understanding from providers about the efficacy, safety and interchangeability of biosimilars [4].

In Europe, biosimilars are usually launched soon after approval and immediately after the patent expiry dates of the originator biologicals. However, in the US this is often not the case, with launch dates coming years after FDA approval in some cases, see Table 1.

Table 1: Approval and launch dates for biosimilars in the US – 2021

^{BI: Boehringer Ingelheim; J&J: Johnson and Johnson; TNF: tumour necrosis factor}

One clear example of an originator company delaying the launch of biosimilars in the US is that of biosimilars to the adalimumab biological Humira. AbbVie brought patent litigation against a whole host of biosimilars makers and eventually made agreements with these companies that would delay the launch of adalimumab biosimilars until June 2023 at the earliest [5]. These deals have led to AbbVie being accused of anti-competitive tactics to stop Humira biosimilars hitting the US market [6].

In contrast, in Europe the first adalimumab biosimilars, Amgevita and Solymbic, were approved (and launched) in March 2017 [7] and since then eight more adalimumab biosimilars have been approved in the region [8].

Another case is that of the etanercept biological Enbrel. Although Sandoz, a division of Novartis, had its biosimilar Erelzi (etanercept-szzs) approved by FDA back in 2016 [9], it is still to launch the product due to ongoing patent litigation [10].

Again, in Europe, the contrast is clear, with etanercept biosimilars Benepali, Erelzi and Nepexto being approved (and launched) in January 2016, June 2017 and May 2020, respectively [7].

Biosimilars on average can cost 30% less than reference biologicals and have the potential to save the US up to US$100 billion in the next five years [11].

AbbVie and Coherus sign licensing deal for Humira biosimilar

AbbVie makes more deals delaying adalimumab biosimilars in the US

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. McGowan S, Jesse M, Biehn B. U.S. Biosimilar Report. AmerisourceBergen, April 2021.
3. GaBI Online - Generics and Biosimilars Initiative. The sluggish US biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Reports/The-sluggish-US-biosimilars-market
4. GaBI Online - Generics and Biosimilars Initiative. US policy brief identifies barriers to biosimilars uptake [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Policies-Legislation/US-policy-brief-identifies-barriers-to-biosimilars-uptake
5. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim finally signs licensing deal for Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Pharma-News/Boehringer-Ingelheim-finally-signs-licensing-deal-for-Humira-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. AbbVie accused of anticompetitive tactics to stop Humira biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Policies-Legislation/AbbVie-accused-of-anticompetitive-tactics-to-stop-Humira-biosimilars
7. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Amgevita and Solymbic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Amgevita-and-Solymbic
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
9. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar etanercept Erelzi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-etanercept-Erelzi
10. GaBI Online - Generics and Biosimilars Initiative. Court rules Amgen’s patents on Enbrel are valid, Sandoz to appeal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Biosimilars/General/Court-rules-Amgen-s-patents-on-Enbrel-are-valid-Sandoz-to-appeal
11. Feldman MA, Reilly MS. A white paper: US biosimilars market on pace with Europe. Generics and Biosimilars Initiative Journal (GaBI Journal). 2020;9(4):150-4. doi:10.5639/gabij.2020.0904.025

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