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Advantages and challenges of biosimilars approved in Europe and the US

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Each biosimilar has its own unique challenges on the market. At the 2019 Generic + Biosimilar Medicines Conference, Dr Amy Gutierrez, Chief Pharmacy Officer of not-for-profit healthcare plan Kaiser Permanente outlined these factors for four blockbuster drugs: bevacizumab, filgrastim, rituximab and trastuzumab [1].

The Generic + Biosimilar Medicines Conference 2019 was hosted by the Association for Accessible Medicines and took place on 4−6 November 2019 in Maryland, USA.

At the conference, Dr Gutierrez outlined some key issues relating to biosimilars, including a section focusing on the unique advantages and challenges of the following four biosimilars:

Bevacizumab
Sold under the trade name Avastin, bevacizumab is a monoclonal antibody treatment for a number of cancer types, including colon, lung and kidney cancer. It was first approved for use in the US in 2004. The first biosimilar version (Mvasi, Amgen) was approved by the US Food and Drug Administration (FDA) in 2017 [2].

Filgrastim
Filgrastim has been sold under the brand name Neupogen and is used to treat low neutrophil count, which can occur in those with human immunodeficiency viruses (HIV) or following chemotherapy. It was approved in the US in 1991 [3]. Patents expired in the US in 2013 [3] and the first biosimilar was approved by FDA in 2015 (Zarxio, Sandoz) [2]. The first biosimilars in the EU were approved in 2008 [4], following patent expiry there in 2006 [3].

Rituximab
Rituximab is a monoclonal antibody used to treat autoimmune diseases such as arthritis and certain types of blood cancer including non-Hodgkin lymphoma and chronic lymphocytic leukaemia. It was approved in the US in 1997 but patents expired in 2016 (and in 2013 in the EU) [3]. Several biosimilars have been approved in the US and EU since [2, 4].

Trastuzumab
Also, a monoclonal antibody, trastuzumab is used to treat breast and stomach cancer that is human epidermal growth factor receptor 2 positive (HER2+). Approved in the US in 1998 [3], it has been sold under the brand name Herceptin. A biosimilar (Ogivri, Mylan) was approved by FDA in 2017 [2]. Europe also approved a biosimilar in 2017 (Ontruzant, Samsung Bioepis) [4].

Gutierrez outlined the unique advantages and challenges of these biosimilars, see Table 1.

Table 1: Advantages and challenges of biosimilars approved in Europe and the US
Biosimilar	Advantages	Challenges
Bevacizumab	Only used in palliative care Approved by FDA for the same indications as the reference product	One of the first biosimilars in the oncology treatment setting No data on switching Two products approved by FDA (causes product selection challenges) Delays in launch due to litigation
Filgrastim	Only one FDA-approved product until recently Experience in Europe (eight biosimilars approved in the EU)	One of the first biosimilars in the oncology treatment setting No data on switching Two products approved by FDA (causes product selection challenges) Delays in launch due to litigation
Rituximab	Data available on switching Two biosimilars approved in the EU	Differences in formulation between reference and biosimilar Involves patient co-pay in the US
Trastuzumab	Data available on switching Four of five FDA-approved products are approved for the same indications as the reference product Five biosimilars have been approved in the EU	One of the first biosimilars in the oncology treatment setting Of the five FDA-approved products, one is without all indications and two have issues with non-superiority Delays in launch due to litigation Evergreening has been used (extending patents by originator companies)
EU: European Union; FDA: US Food and Drug Administration.

Talking about the advantages of biosimilars in general, Dr Gutierrez explained that biosimilars have equivalent efficacy and safety compared to their originator products but with reduced cost. She said concerns about biosimilars have been similar to when generics were first introduced, however, acceptance of generics has increased over time and has enabled improved use of resources. Both types of drug are a key component of maintaining high quality and affordable care, she closed.

Samsung Bioepis and AffaMed to start trastuzumab trial in China

Biocad announces positive rituximab results and plans to enter EU market

Biosimilars of filgrastim

References
1. Gutierrez A. Payor strategies to drive biosimilars access and savings. GRx+Biosims Conference 2019; 4-6 November 2019; North Bethesda, Maryland, USA.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
3. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Mar 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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