Tony Hagen is senior managing editor for The Center for Biosimilars®.
Pharmacists in Ireland say the country is losing out on hundreds of millions of dollars in savings owing to the absence of a biosimilar substitution policy.
The problem of slow biosimilar uptake is not unique to the United States. The Emerald Isle is suffering the lack of these agents, according to the Irish Pharmacy Union (IPU).
The group has called upon Republic of Ireland Minister for Health Stephen Donnelly to bring about a change in legislation that would enable pharmacists to fill prescriptions with lower-cost biosimilars instead of originator brands, calling a policy such as this “the fastest and most effective way to ensure a rapid and meaningful increase in the use of biosimilars.”
The IPU has estimated that Ireland has missed out on $439 million in potential biosimilar savings since 2017.
Currently, the Health Products Regulatory Authority (HPRA) allows European Medicines Agency (EMA)-approved biosimilars to be used interchangeably with originator products “under supervision of a physician.”
The HPRA allows patients receiving originator products to be switched to biosimilars “should a prescribing physician wish to do so.”
Similar to the United States, the HPRA doesn’t require confirmatory clinical studies for every indication of a biosimilar if the reference product it copies has already been approved for those indications. This has enabled physicians to “extrapolate,” or use biosimilars for reference product—approved indications.
Eoghan Hanly, vice president of the IPU, said his group demonstrated the potential savings from biosimilars in a study done 3 years ago. He said the time is right for health authorities to become aggressive about removing barriers to biosimilar adoption. “The finances of the health service have never been in great shape, and the ongoing pandemic will only make that worse,” he said.
The lost savings have already been costly to the health of the population of Ireland, he added. “We are not able to use that money to support people in our health service today, because that opportunity was wasted. Will we be back here again saying the same thing in another 3 years?”
Health authorities in Ireland have also seen pressure from other industry groups to bring biosimilars to bear on the medicine affordability issue. Medicines for Ireland, which represents generic pharmaceutical manufacturers, including biosimilars developers, in 2018 also said that Ireland was missing out on potential savings, but presented a substantially lower figure than that put forth by the IPU. Medicines for Ireland said Ireland's national health system was missing out on $29 million in annual savings. The group said that whereas biosimilar adoption is rising across Europe, in Ireland, usage has hovered at basement levels. Just 2% of the market demand for biologics was filled by biosimilars as of January 2018, it said.
Currently, biosimilars account for just 10% of the market in Ireland for biological medicines, Hanly said.
Instead, biosimilars should be following the example of generics, which since 2013 have increased from 17% to over 40% of the market for small molecule drugs, saving an estimated $1.4 billion, Hanly said. In the United States, by contrast, generic medicines represent 90% or more of traditional medicines (nonbiologics) sold, and laws vary from state to state on generic substitution. Some drugs cannot be automatically substituted.
Estimates vary on the degree of biosimilar penetration in the US market. According to Juliana Reed, a vice president and Global Corporate Affairs lead for Pfizer, biosimilars account for just 2.3% of the US biologics marketplace.
“As the experience of generic substitution demonstrated, allowing community pharmacists to substitute is the fastest and most effective way to ensure a rapid and meaningful increase in the usage of biosimilars,” the IPU said.
“An amendment to the Health Pricing and Supply of Medical Goods Act 2013 would allow pharmacists to substitute a biological reference product with a biosimilar, and the IPU is now calling on Donnelly to legislate for this. Every week that the government fails to implement this proposal is costing roughly [$2.4 million] in potential savings foregone,” Hanly said.
The EMA has worked to improve understanding of biosimilars, and in many countries in the European Union, these drugs are used aggressively, leading to substantial reductions in the use of originator drugs that have lost patent protections.