Biosimilars Market Expected to Soar
Top representatives from the healthcare industry were confirmed to attend the 2nd Biosimilars Congregation which took place in London on February 19 and 20. Ranjith Gopinathan, Frost & Sullivan Program Manager for Life Sciences, Europe Practice participated on the event’s Keynote Panel Discussion focusing on challenges and opportunities in the global biosimilars market.
“Experience in biosimilars development, manufacturing, and commercialization in regulated markets, such as Europe and the US, is limited. Furthermore, reluctance from some physicians and patients to adopt biosimilars due to perceived efficacy and safety issues could have an adverse impact on market penetration. Such uncertainties, in addition to the complex regulatory pathway, compound the risks for biosimilars manufacturers,“ said Gopinathan
Initially, manufacturers of biosimilars will focus on the three protein classes of erythropoiein and human growth hormone due to their recent patent expiry. In the long run, insulin, interferon, and more complex proteins like monoclonal antibodies are likely to emerge. However, some companies may concentrate on certain therapeutic classes depending on their capabilities and strategic fit.
Europe has the highest number of biosimilars approvals in the regulated market and will continue to increase in the near future. Further patent expiries of biologics will likely increase the number of approved biosimilars and players in the market and thereby will bring in a greater number of products that will increase the market size. Biosimilars are currently priced at about 20% to 30% below the original product price.
The 2nd Biosimilars Congregation 2013, which is organized by Virtue Insight, brought together top pharmaceutical, biotechnology, and regulatory representatives under one roof, who addressed the industry key issues ranging from the evolving regulatory landscape and challenges in clinical development to the legal and economic aspects.
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