The need for a framework which allows global development of biosimilars is now crucial - without it, national governments will not be able to benefit from developments such as affordable insulin to treat the upcoming huge increase in diabetes cases, an industry leader has said.
"Biosimilars will also promote significant cost savings that help to safeguard the sustainability of European and indeed global healthcare systems, while ensuring access to high-standard treatments for patients," Gudbjorg Edda Eggertsdottir, president of the European Generic medicines Association (EGA), has told a conference in London.
The global biosimilar development programme which she proposes would be two-pronged, with: - continuous dialogue on European Union (EU)/US negotiations regarding the acceptance of scientific bridging studies; and - revision of the EU "over-arching" biosimilars guideline.
Last November, the European Medicines Agency (EMA) launched a three-month consultation on this guideline, which it is seeking to update to reflect the growing complexity of biosimilars and unique issues concerning their development.
Ms Eggertsdottir also said that European companies should be allowed to manufacture biosimilars in Europe during the patent/Supplementary Protection Certificate (SPC) period for export to countries where no patent exists or has expired, and she also called for research funding and tax breaks for clinical trials to apply to biosimilar developments.
Also critical is an "improved attitude" towards biosimilars in the EU, she added, and she warmly welcomed the work of the European Commission DG Enterprise and Industry's Project Group on Market Access and Uptake of Biosimilars. The group is tasked with identifying obstacles and good practices in EU member states, "whilst providing accurate and unbiased information to counterbalance continuous misinformation and misperceptions regarding biosimilars," she said.
"If we want a sustainable biosimilar medicines industry, we have to be careful to protect this industry in its infancy," the EGA president told the meeting. "Policymakers need to use all avenues possible to increase the competitiveness of the European biosimilar industry, and not only focus on using biosimilars as a means of reducing the price of originator products," she added.
- The global market for biosimilars is expected to reach a value of $17.9 billion by 2017, forecasts Global Industry Analysts Inc (GIA) in a recent report. The EU is currently "way ahead" of the US in the field, notably with publication of the long-awaited guidelines for biosimilar monoclonal antibodies (MAbs) in 2010, and is currently home to a broad array of biosimilars, including epoetin alpha, granulocyte-stimulating factor and recombinant growth hormone, it says.
However, the report suggests that the US will surpass Europe over the analysis period to become the world's largest market for biosimilars, driven by 2010’s passage in Congress of the Biologics Price Competition and Innovation Act (BPCI), which created the means for a regulatory pathway for such products in the near future.
Given the upcoming patient expiries on a number of major biologic drugs, including Roche's Herceptin (trastuzumab) and Rituxan (rituximab), Sanofi's Lantus Insulin glargine) and Amgen's Neulasta (pegfilgrastim), the move "cannot have come at a more appropriate time," says GIA.