Challenges facing the US biosimilars market

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At the 17th Biosimilar Medicines Conference in The Netherlands, Dr Gillian Woolett of US healthcare consultancy Avalere Health discussed challenges facing the biosimilars market in the US and upcoming changes in the Food and Drug Administration (FDA).

US White House V18D13

Although the US has one of the largest biosimilars markets in the world, with the potential to save over US$50 billion on spending on biologicals by 2026, the market continues to face challenges, with only 10 biosimilars launched to date.

Figure 1: Biosimilars approved in the US



Brand Name (Proper Name) Date of Approval



Product (Active Ingredient Date of Approval
Sandoz* Zarxio (filgrastim-sndz) 6 Mar 2015 Amgen Neupogen (filgrastim) 20 Feb 1991
Celltrion* Inflectra (infliximab-dyyb) 5 Apr 2016 Janssen Remicade (infliximab) 24 Aug 1998
Sandoz Erelzi (etanercept-szzs) 30 Aug 2016 Amgen Enbrel (entanercept) 2 Nov 1998
Amgen Amjevita (adalimumab-atto) 23 Sep 2016 AbbVie Humira (Adalimumab) 31 Dec 2002
Samsung Bioepis* Renflexis (infliximab-abda) US; (Flixabi®EU) 21 Apr 2017 Centocor Remicade (infliximab) 24 Aug 1998
Mylan/Biocon Ogivri (trastuzumab-dkst) 1 Dec 2017 Genentech Herceptin (trastuzumab) 25 Sep 1998
Amgen/Allergan* Mvasi (bevacizumab-awwb) 14 Sep 2017 Genentech Avastin (bevacizumab) 26 Feb 2004
Boehringer Ingelheim Cyltezo (adalizumab-adbm) 25 Aug 2017 AbbVie Humira (Adalimumab) 31 Dec 2002
Pfizer Ixifi (infliximab-qbtx) 13 Dec 2017 Centocor Remicade (infliximab) 24 Aug 1998
Hospira/Pfizer* Retacrit (epoetin alfa-epbx) 15 May 2018 Amgen Epogen/Procrit (epoetin alfa) 1 Jun 1989
Mylan GmbH* Fulphila (pegfilgrastim-jmdb) 4 Jun 2018 Amgen Neulasta (pegfilgrastim) 31 Jan 2002
Hospira/Pfizer* Nivestym (filgrastim-aafi) 20 Jul 2018 Amgen Neupogen (filgrastim) 20 Feb 1991
Sandoz Hyrimoz (adalimumab-adaz) 30 Oct 2018 AbbVie Humira (Adalimumab) 31 Dec 2002
Coherus BioSciences* Udenyca (pegfilgrastim-cbqv) 2 Nov 2018 Amgen Neulasta (pegfilgrastim) 31 Jan 2002
Celltrion* Truxima (rituximab-abbs) 28 Nov 2018 Genentech Rituxan (rituximab) 26 Nov 1997
Celltrion* Herzuma (trastuzumab-pkrb) 14 Dec 2018 Genentech Herceptin (trastuzumab) 25 Sep 1998
Samsung Bioepis Ontruzant (trastuzumab-dttb) 18 Jan 2019 Genentech Herceptin (trastuzumab) 25 Sep 1998
Pfizer Trazimera (trastuzumab-qyyp) 11 Mar 2019 Genentech Herceptin (trastuzumab) 25 Sep 1998

A recent presentation by Avalere Health, a consultancy which researches healthcare reform in the US, began by discussing the value of biological drugs to the US public. The US has one of the biggest markets for biological drugs in the world, which is increasing year on year. The total spend for biologicals in the top 20 increased from US$7.7 million in 2012 to US$13.9 million in 2016 (over 90% of total spending for the top 20 drugs, part B).

This is arguably because biological drugs are too expensive in the US. At low prices, biological drugs are uneconomic to produce, but at high prices access to patient populations is reduced. There is thus a need for more sustainable competition amongst biological drugs, regardless of the regulatory pathway by which they were approved.

The presentation by Dr Woolett also discussed recent changes at FDA, including the departure of Commissioner Dr Scott Gottlieb at the end of March 2019. Since Dr Gottlieb joined FDA in 2017, he initiated many changes, including an increase in the number of guidances issued; more product-specific guidance; higher visibility and clinical trials transparency; accelerated initiatives on complex generics; and consideration for broader issues, such as the international context, economics and access. The current acting FDA Commissioner is Dr Norman Sharpless of the National Cancer Institute – where he takes FDA remains to be seen.

Even after FDA approval, there are further challenges for biosimilars, including exclusivity (patenting) and commercialisation. To address these issues, the Trump Administration passed the ‘Biosimilars Action Plan’ in July 2018 to encourage ‘innovation and competition’ among biologicals and the development of biosimilars. In May 2019, FDA released industry guidance on the ‘Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations’.

Dr Leah Christl, previous Director of the Therapeutic Biologics and Biosimilars Staff in the Office of New Drugs, also released three guidance documents relating to biosimilars. These covered approaches to evaluating similarity, considerations in demonstrating interchangeability, and post-approval manufacturing considerations.

Despite these advances, there should be more focus on the consistent regulation of biologicals in the US, which has been found to sell drugs at many times their cost in Europe. AbbVie’s Humira (Adalimumab) for example, sold for five times its cost in Europe [1], leading some to accuse the company of exploiting patent laws to prevent biosimilars from entering the market.

And although the US and Europe have very similar regulatory processes, FDA still lies behind the European Medicines Agency (EMA) in terms of biosimilars approvals, by more than a factor of 4.

Figure 2: Rates of biosimilars approvals in Europe and the US show the US has fewer approvals

Figure 2: Rates of biosimilars approvals in Europe and the US show the US has fewer approvals

Source: EMA: European Medicines Agency, FDA: US Food and Drug Administration, as of 15 June 2019

According to Dr Woolett, part of the problem is the variable requirements for data in different regions of the US. However, she also said that biosimilars face challenges globally, as sales worldwide are less than 1% of originator biologicals. There is therefore scope for cost savings not only in the US but worldwide. 

Figure 3: Global sales by % total market for biologicals and biosimilars

Figure 3: Global sales by % total market for biologicals and biosimilars

Related articles
Achieving consistent regulation for biosimilars

FDA issues guidance on quality-related considerations for biosimilars

FDA issues final guidance on interchangeable biologicals

1. GaBI Online - Generics and Biosimilars Initiative. AbbVie makes more deals delaying adalimumab biosimilars in the US []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jul 19]. Available from: 

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Source: EMA: European Medicines Agency, FDA: US Food and Drug Administration, as of 15 June 2019

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