While coronavirus news rightly dominates the current media and public debate, that is no reason to overlook the landmark 10th anniversary of the BPCIA in the US, which paved the way for the introduction of biosimilars in the world’s largest pharmaceutical market. Indeed, as healthcare systems increasingly struggle under the pressures of increasing demand and limited resources, it has never been more important to put the right measures in place to ensure that patients can access the medicines they need, when they need them.
Different starting points, resulting in varying uptake of biosimilars
The uptake of biosimilars has varied across markets, leading to different environments depending where you look. Understanding these differences, and their causes, can help us address barriers to uptake.
Europe was the first region to fully develop a policy and legal framework for the approval of biosimilars, with the European Medicines Agency (EMA) the first to approve a biosimilar (developed by Sandoz).
The biosimilar market in Europe is widely seen as a success story and an example to follow for other countries, with over 50 biosimilars approved today. The uptake curve gets steeper with every new biologic that comes off patent and is subsequently open to biosimilar competition. Hereby, government involvement, reimbursement and procurement policies have played a significant role in the adoption of biosimilars across the region, and thus been able to generate significant healthcare savings. However, it is important to note that this uptake varies greatly not just by country, but also by therapeutic area, and more needs to be done to create a healthy global biosimilar marketplace.
Clear regulations and policies with smart incentives can make all the difference in driving improved uptake of biosimilars and better collaboration among all stakeholders.
Ensuring continuous engagement of healthcare professionals, patients and payors has also contributed significantly to biosimilar acceptance. Regulatory bodies such as the European Commission (EC) and EMA have taken the lead on driving awareness of the value of biosimilars, resulting in significant progress in promoting uptake.
The approval in Europe was followed by pioneering Sandoz biosimilar approvals in other highly regulated markets such as Canada (2009), Japan (2009) and Australia (2010), where a variety of oncology and immunology biosimilars are now available.
How BPCIA enabled biosimilar uptake in the US
The US introduced the Biologics Price Competition and Innovations Act (BPCIA) as part of the Affordable Care Act (ACA) on March 23, 2010, ushering in the ‘era of biosimilars’ in the US. When the BPCIA was announced, many experts believed that the introduction of biosimilars would help alleviate pressures in the US healthcare system by improving patient access, promoting innovation and helping to reduce the increasing price of biologics.
In practice, we have seen both progress and delays. On the positive side 2015 – albeit almost a decade after the first approval in Europe – Sandoz was the first company to get a biosimilar approved via this newly created US pathway and launched it shortly thereafter. Since then, this biosimilar has spearheaded competition, overtaking the reference medicine and saving the US health care system approximately USD 500 million in less than two years.
However, this has not been the case for all biosimilars launching in the US; the uptake has not always matched the substantial potential to contribute to the sustainability of the market. Introducing biosimilars to the US market has not been straightforward and only a small number of biosimilars have actually become available, despite 26 securing FDA approval (currently only 16 are marketed in the US). Many approved biosimilars are still locked in patent litigation disputes.
Furthermore, once a biosimilar is on the market in the US, many originator companies used contracting and rebates to incentivise payers so that the reference medicine retains market share and effectively inhibits market uptake of biosimilars.
Another crucial point of divergence between the US and Europe is their stances on pharmacist-initiated substitution which is known as interchangeability in the US. The US is the only country in the world that has introduced an additional step in the regulatory review process to establish interchangeability with reference medicines. This step adds additional complexity, for both manufacturers and regulators, with no relevant patient benefit or impact on efficacy or safety.
In the last couple of years, the US FDA has been championing biosimilar education, combatting misinformation and giving more clarity on regulations and procedures. Recently the FDA also teamed up with the Federal Trade Commission (FTC) and convened a workshop on “A Competitive Marketplace for Biosimilars.” Hillel Cohen, our Executive Director of Scientific Affairs, participated in the meeting and confirmed that biosimilar disparagement and misinformation are often encountered in the US and are one of the barriers to acceptance and uptake. Others at the workshop discussed how these activities harm the consumer and may be anti-competitive.
More needs to be done to drive biosimilar uptake in the US
Ongoing Supreme Court discussions regarding the California v. Texas case on whether all or most of the ACA must be overturned can potentially place the future of the BPCIA in jeopardy. As my colleague, Carol Lynch, President, Sandoz US and Head of North America states: “If the ACA is indeed overturned, it will remove the pathway for biosimilars to enter the US market, stripping patients of vital access to medicines and putting the future of biosimilars at risk.” Read more on her view about the case here.
The 10th anniversary of the BPCIA represents a crucial juncture in biosimilars in the US, with the future availability of these critical medicines at stake. Although the US biosimilar market has endured a slow start, their continued growth and success in Europe shows the potential transformative impact they could have in the US.
To sum it up, timely, clear policies and incentives to increase the uptake of biosimilars play a huge part to improve access to biologics for patients. Also, in the US, the world’s biggest market in terms of biologic sales, we see great efforts happening ... it’s a matter of time, to quote Richard.
I’d love to know your thoughts about the prospects for biosimilar access globally and how policies can help to improve this….