Boosting market access and global development for biosimilars

November 10, 2011 2:19 PM

“Boosting Market Access and Global Development for Biosimilars” was the title of the presentation made by Paul Greenland in Warsaw on October 11th. The conference was organized by EGA, European Generics Association and as a regular part of the EGA Conferences, Biosimilars was also one of the hot topics discussed…

Mr. Paul Greenland, Biosimilars Marketing Director at Hospira, as a start for his presentation, gave some information about the healthcare expenditures across the EU. With the aging populations, the average per capita expenditure in the EU as percentage per capita GDP is continuously increasing and this demand increases the healthcare budgets.

According to Mr. Greenland’s presentation, the global biologics expenditure is $116 Billion and the growth rate is 6.3%. USA, the biggest market of pharmaceuticals is again the market leader in biologics and EU, with approximately $30 Billion market coming the second.

As mentioned by several speakers in different conferences, Mr. Grenland has also noted that, biosimilar medicines provide a unique opportunity to help manage the growing costs of biopharmaceutical medicines in Europe and the rest of the world.

Market competition resulting from the introduction of even a small number of cost-effective biosimilars will save the EU several billion Euros annually; more patients can be treated within the same budget and savings can be made in order to fund new ‘high-cost’ treatments.

But he also added that, policy makers need to re-think market access measures to ensure that long-term benefits of biosimilars can be achieved. Besides, “biosimilars development requires harmonisation between global agencies to prevent replication of data and increased cost” he noted.

He also showed some figures about the market penetration of biosimilars in the EU. According to IMS MIDAS Unit database (MAT volume to June 2011), only a few countries has around 20% market share for epoetin biosimilars.

Germany is one of the most successful market for biosimilars; Epoetin (ESA) biosimilars have 25% of German market but this is due to the regional quotas: Rapid penetration facilitated by biosimilar EPO quotas that range from 10-40% across German health regions. EPO biosimilars in Germany resulted in savings of >€60m in the first year.

As a summary, Mr. Greenland underlined following points at the end of his presentation:
– Establishing a strong and vibrant biosimilar industry in the EU is essential to increase competition and reduce health expenditure on biopharmaceuticals over the long term
– Biosimilars are not generics – they are more costly to produce than small molecule generics and have slower market entry
– To realise the benefits of biosimilar introduction, policy makers must help to establish supportive market access mechanisms for biosimilars
– Failure to support biosimilar market access in the short term may limit investment in future biosimilar development
– Biosimilars should not be used to drive price reductions from originators
– Harmonisation of global biosimilar regulation is critical to the continued viability of biosimilar developments and increased affordability, availability and access to biopharmaceuticals globally


Reference: Greenland P. Boosting Market Access and Global Development for Biosimilars – EGA-EU Polish Presidency Conference; 2011 Oct 11; Warsaw, Poland.


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