02 February 2010
Biosimilars should capture significant share of Biologicals market in Europe
Although currently poorly developed, the biosimilars market segment but is widely expected to become a significant commercial segment over the next few years, capturing a healthy percentage share of the biologicals market, says Dr Peter Norman.
The biosimilars market segment is poorly developed but is expected to become a significant commercial segment. How well and rapidly this develops depends on a number of factors. In the US there is strong lobbying both in favour of and against biosimilars, while the permissibility, or not, of substitution for a branded biological, and the pricing levels of biosimilars are all likely to influence exactly how the market develops. But progressive patent expirations will open up increasingly greater commercial opportunities, with 2014 likely to be a year of major significance. That same year should see the emergence of biosimilars of one or more anti-TNF products and is likely to see the introduction in the US of epoetin alfa biosimilars.
What is clear is that the European market for biosimilars will grow steadily as currently approved products improve market penetration, and as new products enter the market, with the first interferon biosimilars likely to be approved in the near future, followed by anti-TNF products in 2014, oncology antibody products in 2015, then darbepoetin biosimilars in 2016. The current absence of enabling legislation in the US is a limiting constraint and such legislation appears unlikely to become law before 2013. But, even if enacted by 2011, the strength of Amgen’s patents relating to epoetin alfa will limit the commercial opportunities available before 2014 to biosimilars of interferons and G-CSF. The less-developed Japanese biological market should see biosimilars become available by 2012, with epoetin and G-CSF expected to be the first products approved after Omnitrope, but other biosimilars are likely to emerge later in Japan than elsewhere as a result of the belated approval of the original biological products.
The epoetin market segment ($10bn in 2008) is the most substantial near-term opportunity for biosimilars, but safety concerns, the strong market position of second-generation products and Amgen’s US patent portfolio will all limit the commercial opportunities until darbepoetin biosimilars become available. Only in Europe are the epoetin alfa biosimilars likely to generate significant revenues prior to 2014. The dominance of the G-CSF segment , worth $5.1bn in 2008, by the second-generation product Neulasta which has a 54% market share, severely hinders the commercial prospects of filgrastim biosimilars, with the availability of pegfilgrastim biosimilars (in 2016?) required to see significant uptake of G-CSF biosimilars. The $2.6bn value interferon alfa segment is dominated by second-generation products for which biosimilars cannot be expected before 2015. The more attractive interferon beta segment ($5.5bn in 2008) offers better commercial prospects for biosimilars. The rejection of an MAA from Biopartners in 2009 appears to ensure that no such products will become available before 2010 and may be blunted if Biogen succeeds with its development of a second-generation product.
“The anti-TNF segment offers the best commercial opportunity for biosimilars, with the three leading products all likely to face competition from biosimilars in Europe and/or the US by 2016, with such products emerging in 2014,” notes Dr Peter Norman, author of the report Biosimilars: A Growing Market. But such products are more complex proteins than those for which biosimilars have been developed to date, suggesting that approvals may be delayed. Their market penetration is likely to be attenuated because of the multiple conditions for which the anti-TNF products are approved, thus requiring companies to target a specific indication in seeking approval of their biosimilar. By 2016 the oncology antibody segment ($16.6bn in 2008) should also offer opportunities to a number of biosimilars, but market entries may be delayed both by technology issues (product complexity) and by patent issues (because of the extensive cross-licensing of technologies between companies).
By 2020 the biosimilars segment may account for 10% of the biologicals market
Many forecasts relating to the development of the biosimilars market seem over-optimistic, and appear to assume a rapid resolution of the legislative impasse in the US with respect to the approval of biosimilars, and overlook the strength of Amgen’s patent position with respect to epoetin alfa. Assuming a later passing of US legislation (by 2012 rather than 2010), the value of the biosimilars market segment will continue to be dominated by European sales revenues in 2012, and this is likely to account for about 0.6% of the fast-growing biologicals market. By 2016 this share should have grown to 2.6%, with the US overtaking Europe as the leading source of revenues from such products. The greater opportunities after 2016 should see substantial increases in the sales of biosimilars and by 2020 this segment may command a 10% share of the total value of the biologicals market.
