The 6 Key Policy Factors to Ensure Biosimilar Market Sustainability

Magnus Bodin, senior director and head of international access and policy at Biogen, presented warning signs for unsustainable biosimilar markets as well as key factors needed to create effective policies and future-proof biosimilar markets globally.

Sustainable biosimilar market access policies should promote affordability, accessibility, and availability through free and fair competition among multiple biosimilar suppliers, according to Magnus Bodin, senior director and head of international access and policy at Biogen.

Bodin spoke at the Festival of Biologics USA in in San Diego, California, during his session on what makes a biosimilar market sustainable and best practices for ensuring biosimilar success in the future.

He started by showing how Poland has had incredible biosimilar uptake since 2017, demonstrating how immunology biosimilars have achieved 72% market share by 2021. However, those metrics didn’t tell the full story, as Poland actually has some of the worst biosimilar accessibility in Europe, thanks to ineffective policies.

“You could argue this is a perfect example of a sustainable biosimilar market…. But the commonly used metric of biosimilar penetration doesn't speak very much to sustainability or a holistic view of the system. Actually, if you compare Poland…with Norway, which is best in class in this therapeutic example, the difference is 25 times higher treatment rates in Norway vs Poland,” he explained.

In addition, Bodin highlighted that between 2018 and 2023, Austria saw very little change in number of biosimilar competitors on the market and percentage of market penetration, which he said was a sign that the country had ineffective policies. Bodin said that Austria’s challenges stemmed from the country having only 1 biosimilar policy and not making an effort to add new ones.

“If you build a policy around just writing down the price with little support to biosimilars, you could risk having a highly unsustainable market and you can see the competitive or the appetite from competitors to launch and remain involved.”

Bodin provided a list of 6 procurement models and policies that will be key to future-proofing biosimilar markets, including:

  1. Allowing free, fair, and open competition
  2. Balanced decision-making models that take a broad set of stakeholders into account
  3. Selection criteria that consider factors other than price
  4. Tender systems that allow for multiple winners
  5. More transparency in development planning and contract implementation
  6. Measure and communicate value of procurement policies to ensure appropriate reinvestment of savings

He championed free market competition and pricing as the most effective way to drive long-term sustainable savings and improved patient access. Additionally, policies that consider factors other than price could slow down price erosion and reward small innovation and enhancements to the patient experience. Bodin continued by saying that manufacturers should be incentivized to drive supply chain excellence by clearly communicating timelines and driving contract implementation and adherence.

Regarding tender systems, Bodin said, “We have seen multiple examples—with generics and biosimilars—of supply shortages. And one way of mitigating this is to break down contracts or tenders into multiple awardees. This could be done for instance in a framework or a ranking. Or it could be done by formalizing who is the backup solution if one player fails to supply.”

Reference

Bordin M. What is a sustainable biosimilar market? Presented at: Festival of Biologics USA; April 15-16, 2024; San Diego, CA.