by Janelle Dumalaon
BERLIN, Dec 1 (APM) - One of the biggest challenges for biosimilars companies launching new products will be introducing new delivery devices to patients already accustomed to those supplied with the branded versions, an analyst has told APM.
Joshua Owide, GlobalData’s director of healthcare industry dynamics, said “barriers posed by delivery devices associated with incumbent therapies such as Humira or Enbrel,” will likely affect their success.
His comments come ahead of the Drug Information Association’s Biosimilar Conference in Berlin, which begins on Tuesday, and add to a growing list of challenges faced by biosimilar companies hoping to launch near-copies of some of the biggest selling drugs in the world, such as Humira (adalimumab) and Remicade (infliximab). (APMMA 40280) (APMMA 40299) (APMMA 37913)
Owide pointed out that original biologics come with highly sophisticated devices, which patients have become accustomed to using for self-administration. This could make patients unwilling to switch to a biosimilar with a different delivery device, he said. However, biosimilar manufacturers are aware of this, he added.
“Sandoz is testing a subcutaneous formulation of its Enbrel biosimilar in Phase III, a clear indication of its desire to be competitive following approval,” Owide said.
Steffen Thirstrup, director of regulatory and health technology assessment consultancy NDA Group, who is scheduled to speak at the conference, told APM he believes the biggest hurdle remains dissuading physicians and patients from a reluctance to use the products, as well as a bridging their knowledge gap.
There is "a reluctance" to use biosimilars, and a lack of scientific and legal understanding behind biosimilar approvals, he said in a telephone interview.
"This knowledge gap will not only be a direct challenge for the manufacturers but also for those healthcare systems and payers who would like to introduce these products in order to simulate competitions and reduce the costs," he told APM ahead of the conference.
He said that while scientific acceptance has been partially won via the first regulatory approvals, wider market access for biosimilars would still depend on physicians and patients. How the first monoclonal antibody biosimilars will perform clinically and commercially will also do much to shape biosimilar acceptance, added Thirstrup.
“There is no doubt in my mind that a successful market introduction and unproblematic and uneventful clinical update of these first monoclonal biosimilars will be very important in the acceptance of biosimilars in general and for the introduction of other monoclonal biosimilars in other therapeutic areas such as oncology,” he said.
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.
The five top-selling monoclonal antibodies are AbbVie's Humira (adalimumab), Pfizer's Enbrel (etanercept), and Roche's MabThera/Rituxan (rituximab), Avastin (bevacizumab) and Herceptin (trastuzumab).
Meanwhile, while not identifying any specific markets, Thirstrup speculated that countries with well-developed generics markets were most likely to embrace biosimilars more quickly.
“In general I would say that some EU markets are more adapted to generics and have reimbursement systems focused on price-cuts through generic competition. These countries would in my view be those that would be ready for biosimilars at a faster rate than those countries where use of generic is less pronounced,” he said.
Voices in Germany have been varied as to the need for measures to push biosimilar use in Germany, such as the biosimilar quota. German generics lobby group ProGenerika has consistently pushed for biosimilar quotas beyond existing ones for epoetin and filgrastim (APMMA 35146), while pharma lobby group VfA has rejected the idea (APMMA 9280).
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