5 Takeaways About Biosimilars at ISPOR

Earlier this week, the ISPOR 22nd Annual International Meeting convened in Boston, Massachusetts, with presentations on a wide range of topics, including value assessments, drug prices, health policy in the United States, and affordability. While many of the presentations had a US slant, ISPOR’s members represent 114 countries. A session on biosimilars took a global view, comparing the US to Europe.

Here are 5 takeaways from a session on the opportunity for biosimilars in the US.

1. Limited uptake of biosimilars

There is a lot of untapped potential in the US compared with Europe, which makes sense since Europe has a head start in the space, explained Michael F. Drummond, MCom, DPhil, University of York. It can rarely be said about the US, but in the case of biosimilars, America is “an emerging market.”

While only 4 biosimilars have been approved in the US, only 2 have made it to market; however, there are a lot in development. The 10-year head start that Europe has means there are now 21 approved overseas, according to Monique Martin, PharmD, MSc, MBA, of inVentiv Health.

2. Potential for savings and improved outcomes

There is a lot of expectation that the entry of biosimilars will present a cost savings opportunity. In European markets, with a big uptake of biosimilars, cost reductions have been between 20% and 40%, Drummond said. Not only will biosimilars be cheaper, but they offer cost savings opportunities simply through expanding choices for treatment.

In addition, Drummond added, biosimilars allow improved patient outcomes because healthcare systems with limitations will now be able to treat more patients with access to cheaper alternatives.

3. Patent litigations

All 4 biosimilars that have been approved in the US have gone through patent litigation, said Dennis W. Raisch, PhD, MS, RPh, of the University of New Mexico. The existence of so much litigation, which has delayed approved biosimilars from reaching the market, shows that regulations in the US have not achieved what they were supposed to.

“The patent dance hasn’t come to fruition very well,” Raisch said. “These have all gone through litigation, sometimes protracted” and some are still pending court decisions.

4. Leveraging biosimilars in the US

Even if payers don’t switch from the originator drug to a biosimilar, they can still leverage the entry of biosimilars as a way to reduce market prices, said Keith Kelly, BBA, of inVentiv Health Consulting. This might be what happens frequently, because there is a lot more effort—outreach to physicians, to patients, and to news organizations—for a payer to cultivate uptake of a biosimilar over the originator drug.

“This is the competitive barrier that biosimilar manufacturers will face,” he said. “I am concerned on their behalf.”

5. Uptake varies greatly by country in Europe

On average, the growth of biosimilar penetration in Europe is 6% per year, which isn’t very high, Martin said. So, the longer a biosimilar is on the market, the higher uptake is, but the time it takes to get to market also impacts uptake, she added.

The first biosimilar, Omnitrope, hasn’t made a lot of progress in Europe. The average uptake is about 23%, and it’s only that high because a few markets have very high uptake compared to the majority of European markets. In addition, the price discount is only an average of 8%.

However, the situation is different with Zarxio, which has an average market uptake of 80% in Europe and an average price discount of 32%.