It’s going to be an issue for accessibility of medicine if competing companies won’t produce biosimilars of drugs that aren't as lucrative as biosimilars of blockbuster medicines, a panel of European experts said at the Medicines for Europe Biosimilar Medicines Virtual Summit 2021.
“It’s well known that development costs of biosimilars are very high compared with the development costs of generics,” said moderator Adrian van den Hoven, director general of Medicines for Europe. “Are we, in Europe, going toward a market where biosimilars will be up only against very big blockbuster biologics, whereas the smaller, more medium-size biologics won’t be worthwhile?” he asked.
In Denmark, the market for biosimilars is small (population 6 million), and yet there has been robust interest from biosimilars developers. Health authorities have to be careful not to get into a situation where prices are too low that companies might withdraw their bids to supply biosimilars, said Dorthe Bartels, senior strategic advisory at Amgros, the national procurement organization for Denmark.
However, she said, a positive sign is that in China many companies are developing biosimilars for a broad range of biologics that are not limited to the most lucrative of biologics.
Minimum Returns Threshold
Given the high cost of developing biosimilars, manufacturers might have minimum sales revenues requirements, which could preclude them from producing biosimilars for relatively minor indications, said Phillip van Wilder, a professor at Université Libre de Bruxelles School of Public Health in Belgium. This issue is connected to the problem of sustainability of biosimilars and needs to be part of the general discussion, “because it’s something where resilience is necessary,” he said.
Europe may be perceived as a place where biosimilars have in general been widely accepted, compared with the United States, and yet biosimilar success varies across EU member states. Panelists discussed the value of “top down” approaches to impose the use of biosimilars where market dynamics appear not to be working.
The European Union as a whole cannot force the use of biosimilars on member states, but it can influence biosimilar uptake via recommendations issued to countries that receive money from the European Union, van den Hoven said. “Many EU countries are now in the situation where they are receiving recommendations from the [European Commission], so should the commission be recommending or telling member states “you should have more biosimilar competition in your market?” he asked.
Bartels said that based on the Denmark experience, it might be better to use an education approach to communicate to stakeholders the gains that have been achieved by using biosimilars. For example, in Denmark, the country has achieved an initial 85% discount on the cost of originator adalimumab. “In the rheumatoid arthritis area, around 15% more patients have gained medicine, because we have introduced biosimilars, so maybe the story should be around the success of introducing biosimilars and the treatment for patients,” she said.
Top-Down Approach
A somewhat authoritarian policy that imposes biosimilar uptake could be of value in some Central Europe countries where biosimilar competition has not evolved as hoped, said panelist Tomas Tesar, an associate professor of pharmacy with Comenius University in Slovakia. There tends to be segmentation in these markets where originator biologics end up not competing head-to-head with biosimilars. “These are issues which could be solved by a top-down approach,” Tesar said.
Biosimilars have been approved as monotherapies for various indications, but more and more, pharmaceutical companies are developing combination medicines, and the panel viewed this as an opportunity to channel more biosimilar use, because these combinations of 2 or more drugs, which end up getting approved by regulators, could include 1 or more biosimilars from the get-go. The use of biosimilars has the potential to bring down the cost of these combination therapies. “We’ve seen in some countries, mainly in the United Kingdom, that expensive innovator compounds used in combination with biosimilar versions are cost-effective and are therefore accessible to the patients,” van den Hoven said.
This is happening in Denmark, Bartels said. Biosimilar use is written into applications for marketing of biologic combinations. “I think that’s actually the way forward. It will be cheaper for all of us.”
Combining innovator products with biosimilars as a concept appealed to other members of the panel. However, “we need to find a policy in which there is at least some competition in the market between various providers of the same products,” van Wilder said.
European countries have tender systems that allow drug companies to bid to obtain near exclusive license to supply drugs, although countries also work with multi-tender agreements that allow more than 1 supplier. In Denmark for adalimumab, although it is a small country, the tender was awarded to 2 bidders because of concerns that a single supplier might not be able to supply the whole market consistently. For now, that’s the only multi-supplier arrangement in Denmark, Bartels said, but it’s possible it might be tried with other drugs.
Will It Get Easier?
Europe has biosimilars approved for 17 different originator drugs, and another 30 innovator biologics are expected to lose market exclusivity over the next 10 to 15 years, according to IQVIA. Van den Hoven asked the group to speculate whether or not the next wave of biosimilars can be incorporated into practice with greater ease than the ones that came before.
Ireland is still on the beginning end of the biosimilar adoption curve, said Bernard Duggan, a chief pharmacist with Trinity Centre for Health Sciences at St James’ Hospital in Dublin. “We’ve come a long way in the last 2 years.” That experience likely could make uptake of the next series of biosimilars much swifter, he said. “I supposed we’ve learned a lot as we’ve gone through the process. It’s not one-size-fits-all. There will be slight nuances that need to be considered, but I think we have a framework here now that, if we’re called upon again, could be used to promote further uptake of other biosimilar medicines.”
