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24/02/2022 What Does 2022 Hold for Biosimilars in the US?



Gillian Woollett
Vice President
Head of Regulatory Strategy and Policy
Samsung Bioepis

The start of the new year brings with it the chance to reflect on the past year and set new goals for the next one. Whether or not we achieved everything we wanted, having a new year’s resolution invigorates us with the sense of a fresh-start and inspires us to improve ourselves and those around us. Similarly, our company and our industry can reflect on the past year and forecast a year ahead that fulfills our promises to patients around the world whilst adding to our commercial successes.

In 2022 our collective efforts are going to matter as well as our regulatory strategy and policy. Biosimilars are showing promising growth globally, but we are faced with somewhat less than expected outcomes for biosimilars in the US market. And if the US, as the biggest single market in the world, shows weak adoption, are biosimilars going to be threatened worldwide? Hence, our responsibility is to impact the US for our sake and theirs.

But let’s start with the blessings. Last year was a year of major firsts for biosimilars in the US – the first ever FDA interchangeable designation which was for an insulin producti, the first interchangeable monoclonal antibodyii and the first biosimilar product approved in the therapeutic area of ophthalmologyiii. The pace of biosimilar approvals was slow and COVID-19 had an additional impact on the already slow adoption of biosimilars so these are all the more compelling achievementsiv. And the achievements can be credited across companies, regulators and from sponsors around the world. Again, science - as our one global language - enabled progress across borders despite the noise of politics.

However, perhaps like most new year’s resolutions, we must recognize that the US market is a product of its own unique accumulated history and policy. But that can be our opportunity too. If ever there was a time for solutions to high drug prices it is now, with the success of originator biologics indicating that biosimilars will be ever more necessary for sustainable health care in the future.

So what is the hold up in the US? The delay in broader adoption of biosimilars in US is often attributed to a combination of the healthcare professionals’ clinical preferences due to their lack of understanding of biosimilars, financial incentive issues for payers and integrating biosimilars into health systems.

While all of these issues cannot be resolved overnight, we can only continue our efforts to educate the public - especially the healthcare providers, and other stakeholders to improve understanding of biosimilars and to boost confidence in their use. This is do-able and our leadership needed, indeed invited. The great news is that biosimilars are expected to provide the same clinical outcomes for patients at a lower price and so offer great value to all stakeholders. The science is our bedrock and we simply need the results to be seen more broadly. So that is what we will do in 2022!


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