Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market

Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas. | Image Credit: WrightStudio - stock.adobe.com

Streamlining regulatory processes, addressing patent abuse, and evolving reimbursement models to ensure sustainability can help overcome barriers and expand biosimilars into new therapeutic areas, according to Sonia T. Oskouei, PharmD, vice president of biosimilars and specialty at Sandoz.

Oskouei spoke at the 2025 Festival of Biologics USA from April 23-24 in San Diego, California, on how to bridge the biosimilar void through solutions that create a more sustainable market. In 2015, the first biosimilar, Zarxio (filgrastim-sndz), launched; it has generated $1.6 billion in savings for the US health care system between 2016 and Q1 2022.

Like many other speakers, Oskouei emphasized the 118 biologics that will lose patent protection between 2025 and 2034, representing a $234 billion market opportunity, but currently only 12 of those medicines have biosimilars in development.

“To look at it more in a positive light, the biosimilar void is not permanent. It's a pivotal moment to be claimed. We do have tools, expertise, and, naturally, more experience than ever with these products, not just in the US, but globally. We should be able to use those more and more to shape policy makers and stakeholders to build a biosimilars market that is sustainable and offers patients access to these critical treatments,” Oskouei explained.

The regulatory process for developing biosimilars has not evolved at the same pace as technological advancements, creating a gap between potential and reality. Significant barriers in the biosimilar landscape, from patent abuse and supply chain disruptions to misaligned stakeholders, regulatory complexity, a lack of health care provider awareness, and dynamic environments, all contribute to this issue.

For example, the long, complex, and expensive process of biosimilar development prevents the ultimate availability of medicines. Oskouei proposed a tailored regulatory framework for biosimilar development that maintains high scientific standards to streamline the approval process and improve overall patient access.

The average sales price model for reimbursement is also not sustainable, and evolving this model is necessary to ensure long-term sustainability and investment in biosimilars, she said. Additionally, the Medicare Part B reimbursement system and misaligned incentives create significant barriers. Evolving reimbursement models for medical benefit biosimilars can transform this barrier into an opportunity by encouraging a competitive and sustainable biosimilar market.

“These are barriers and we should not consider them roadblocks. There's a key difference. These are not insurmountable, and there's distinct things that we could do to take action and make sure that we make progress again. We're in a very pivotal time in this space where we need to be more bold than ever, in my opinion, to ensure that we have the continued investment to bring biosimilars to market,” Oskouei stated.

Patent thickets and anticompetitive tactics by originator companies delay biosimilar entry, prioritizing profits over patients, Oskouei said, which remains another challenge of patent abuse. Policy makers can implement legislative or regulatory solutions to stop delay tactics that ultimately limit access to affordable treatments.

According to Oskouei, tariffs directly threaten the affordability and accessibility of biosimilars, necessitating bold advocacy and policy engagement. The health care ecosystem's barriers, not biosimilars themselves, prevent the rollout of high-quality, lower-cost treatment options.

Safeguarding the biosimilar industry amid a dynamic environment is essential to unlock its full potential for patients. Collaboration, especially through partnerships with US policy makers and advocacy for positive change, will further progress in this industry.

“It's not really just a policy issue, I actually think it comes down to a moral issue. Every dollar wasted that could have been saved is preventing advancement in health care delivery from care research or the next generation of innovative treatment options. We are in an exciting time with biosimilars,” Oskouei concluded.

Reference

Oskouei ST. Bridging the biosimilar void: solutions for a sustainable market. Presented at: Festival of Biologics USA; April 23-24, 2025; San Diego, CA.