by Helen Collis
LONDON, Oct 28 (APM) - The biggest challenge facing companies launching biosimilars in Europe is the creation of sustainable, competitive environments that make it worth their while pursuing commercialisation within each country, an expert told APM.
In a telephone interview on Tuesday, Victor Mendonca, head of pharmaceutical policy and health economics at the European Generic Medicines Association (EGA), said: “The concern is the sustainability of the market. We already have examples of companies that have left the biosimilars market in some countries in Europe as they were deemed to be unsustainable.”
His comments come as originator monoclonal antibodies face a patent cliff in Europe.
On top of European variations in the regulatory environment, new biosimilars will also face tough competition through likely price cuts of originator products. But Mendonca said, ultimately, biosimilars success will depend on each European government setting out the framework for sustainable regulatory, pricing and reimbursement environments.
“What we are concerned about is that governments put in the measures to allow the uptake of biosimilars and access for patients… we believe it’s up to governments and regulators to create that competitive environment.”
Currently, the potential biosimilars markets remains “quite small”, he said, but by 2020 the opportunity for biosimilars sales is estimated at $70 billion globally, according to IMS Health data.
Among one of the first monoclonal antibodies to lose its patent is Merck Sharp & Dohme’s (MSD) Remicade (infliximab), which is set to lose protection in Europe in 2015.
MSD is already preparing for biosimilar launches. In Germany it has secured discount contracts for the majority of the market, a move the local generics association ProGenerika claimed will “destroy” competition before it has started. (APMMA 40161)
In France, the drugs economic committee CEPS has imposed a price cut on Remicade as standard procedure for the imminent launch of any biosimilar. (APMMA 40180)
Mendonca said he was unable to comment on any biosimilar pricing strategies or whether EGA members were concerned over such changes to the price of originator products.
“What we can say regarding Remicade, and all other biological medicines, is that we expect biosimilars will help countries around Europe to generate savings to payers and to also increase patient access to biologicals.”
Elsewhere, any further potential Remicade pricing strategies for Europe were being kept under wraps by MSD. An emailed statement from the company pointed out that in the UK the patent for Remicade is valid until February 2015, but the company did not hint of any price changes in this market.
“MSD does not currently know the list price of biosimilar infliximab or how it will compare to Remicade in relation to long-term treatment effect, switching or related overall healthcare costs, patient support or satisfaction.
“MSD expects to remain competitive within the market once Remicade is off-patent,” the company added.
MSD underlined that it had 16 years of long-term clinical data and real-life experience in over 1.8 million patients worldwide, with an established safety record.
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