Biosimilars and Follow-On Biologics: World Market 2013-2023

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Page 67 www.visiongain.com Biosimilars and Follow-On Biologics: World Market 2013-2023 4.4.8 France: Biosimilars Submarket 2013-2023 Compared with other leading Western European nations, pharmaceutical spending, per capita, is high in France, while generic drug use is low. In France, low uptake of generics is a result of comparatively low prices for branded drugs, as well as many patents for leading products being extended in the country. Low uptake of generics is matched there by low uptake of biosimilars, when compared other leading nations such as the UK and Germany. In France, biosimilars account for only around 15% of prescriptions in the EPO, filgrastim and somatropin markets. For EPO, the level of biosimilar uptake is estimated to be just 5%. In that submarket, as well as for growth hormones, low uptake is the result of mandatory price reductions for the reference biologics and biosimilars. These price reductions mean that there is little difference between the cost of the reference biologic and the biosimilar. Generally speaking, though, biosimilars are launched at a discount of 20% over the reference biologics in France. Reports suggest that doctors in France have not yet gained confidence in prescribing biosimilars, giving another possible explanation as to why uptake remains low. The reason given is that biosimilars are relatively new to the market - confidence in these drugs will grow in the coming 10 years, visiongain predicts. This growing confidence will drive revenues to $321m in 2017, up from $61m in 2012 (Table 4.9 and Figure 4.9). Growth in the second half of the forecast period will be driven by the launch of biosimilar mAbs. By 2023, the French biosimilars submarket will be worth $1,146m, having grown since 2012 with a CAGR of 30.6%. Visiongain predicts that France will fall further behind Germany, in terms of market size, although its European market share will increase relative to that country. 2012 2013 2014 2015 2016 2017 Submarket ($m) 61 75 119 170 236 321 Annual Growth (%) 23 58 44 39 36 CAGR (%) 39.4 2018 2019 2020 2021 2022 2023 Submarket ($m) 423 547 682 832 977 1,146 Annual Growth (%) 32 29 25 22 18 17 CAGR (%) 23.7 Source: visiongain 2013 Table 4.9 French Biosimilars Submarket: Revenue Forecast, 2012- 2023

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Transcript of Biosimilars and Follow-On Biologics: World Market 2013-2023

Page 1: Biosimilars and Follow-On Biologics: World Market 2013-2023

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Biosimilars and Follow-On Biologics: World Market 2013-2023

4.4.8 France: Biosimilars Submarket 2013-2023 Compared with other leading Western European nations, pharmaceutical spending, per capita, is

high in France, while generic drug use is low. In France, low uptake of generics is a result of

comparatively low prices for branded drugs, as well as many patents for leading products being

extended in the country. Low uptake of generics is matched there by low uptake of biosimilars,

when compared other leading nations such as the UK and Germany. In France, biosimilars

account for only around 15% of prescriptions in the EPO, filgrastim and somatropin markets. For

EPO, the level of biosimilar uptake is estimated to be just 5%. In that submarket, as well as for

growth hormones, low uptake is the result of mandatory price reductions for the reference biologics

and biosimilars. These price reductions mean that there is little difference between the cost of the

reference biologic and the biosimilar. Generally speaking, though, biosimilars are launched at a

discount of 20% over the reference biologics in France.

Reports suggest that doctors in France have not yet gained confidence in prescribing biosimilars,

giving another possible explanation as to why uptake remains low. The reason given is that

biosimilars are relatively new to the market - confidence in these drugs will grow in the coming 10

years, visiongain predicts. This growing confidence will drive revenues to $321m in 2017, up from

$61m in 2012 (Table 4.9 and Figure 4.9). Growth in the second half of the forecast period will be

driven by the launch of biosimilar mAbs. By 2023, the French biosimilars submarket will be worth

$1,146m, having grown since 2012 with a CAGR of 30.6%. Visiongain predicts that France will fall

further behind Germany, in terms of market size, although its European market share will increase

relative to that country.

2012 2013 2014 2015 2016 2017

Submarket ($m) 61 75 119 170 236 321

Annual Growth (%) 23 58 44 39 36

CAGR (%) 39.4

2018 2019 2020 2021 2022 2023

Submarket ($m) 423 547 682 832 977 1,146

Annual Growth (%) 32 29 25 22 18 17

CAGR (%) 23.7

Source: visiongain 2013

Table 4.9 French Biosimilars Submarket: Revenue Forecast, 2012-2023

Page 2: Biosimilars and Follow-On Biologics: World Market 2013-2023

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Biosimilars and Follow-On Biologics: World Market 2013-2023

4.4.9 Biosimilar Uptake is High in the UK In 2012, biosimilar revenues in the UK totalled $40m, accounting for 12.5% of the EU biosimilars

submarket. Uptake for biosimilars in the UK is higher than for France, with around two thirds of

NHS filgrastim prescriptions being filled with biosimilars. Price and cost effectiveness are two

important features of the UK pharmaceutical market, visiongain notes. However, upon launch

discounts for biosimilars are not as high as has been seen in other countries. For example, In July

2009, Sandoz’ Zarzio was launched on the UK market with a 10% discount over Neupogen,

although this may be the result of a low price for the reference biologic. Pricing is a key element of

entering the UK market, with only drugs found to be cost-effective - as determined by the criteria of

the National Institute for Health and Care Excellence (NICE) - available through the NHS. While

generic drugs are exempt from pricing regulation schemes in the UK, biosimilars are covered.

As with other leading European markets, biosimilar substitution is not possible in the EU. The UK

Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced a number of

safeguards to prevent against accidental substitution. In 2008, for example, it advised that doctors

should always prescribe biological drugs by brand name to avoid confusion for the pharmacist. In

addition, packaging for biosimilars in the UK must be printed with a black triangle to identify the

product as a follow-on biologic. The UK was among the first countries to introduce such a

regulation, although similar EU-wide rules are set to take effect in 2013.

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Figure 4.9 French Biosimilars Submarket: Revenue Forecast, 2012-2023

Source: visiongain 2013