Returning from CPhI 2019, in Frankfurt, the words of Eric Langer, President of Bioplan Associates, have stuck with me.
Describing the biosimilar industry as a ‘workhorse’, I wondered…
As well as providing a cheaper alternative to biologics, what role do biosimilars play in the biopharma industry? Are they really carrying it? And what barriers are preventing the biosimilars market from developing further?
In biopharma, ground-breaking discoveries come thick and fast. Cell and Gene Therapy, Crispr Gene Editing technologies and NGS are revolutionising the space – making it understandable why we sometimes overlook existing technologies and treatments like biosimilars.
Just because it’s understandable, doesn’t make it right.
Biosimilars have the potential to change the lives of millions of patients, thanks to their cost-effectiveness and accessibility.
In 2017/18, NHS England saved more than £200m by adopting biosimilar medicines – setting itself a target to save a further £300m by 2021. With patents for more blockbuster biologics coming to expiration and more biosimilars being approved, this is not an unrealistic goal to help increase patient accessibility.
While being cost-effective themselves, biosimilars also drive down the price of innovator products – making pricing more competitive across the board. This again, leading to greater accessibility for patients.
Biosimilars aren’t innovative, they’re just products that resemble the original innovator. However, that’s not to say that they don’t help drive innovation. The competition they provide motivates innovator companies to carry on innovating and stay ahead of chasing competitors.
This leads to the development of better products, ‘biobetters’, or new discovery projects focussing on new therapeutic areas and treatments. There are currently more than 560 biobetters in global pipelines.
We’ve seen the advantages of a strong biosimilar market throughout European healthcare. Its quick uptake is thanks to regulations set in 2004 to define a clear path for the biosimilar market access, allowing companies to define their biosimilar strategy and timeline.
In some European countries, biosimilars occupy a 100% market share versus the referenced product, meaning greater patient access to treatment.
The Asian Market for Biosimilars is huge too.
In China, the market for biosimilars has seen a compound growth of 25% for the last several years, with most of its approved 390 biologic drugs being biosimilars. India is also a major hub, home to global players like Biocon, Lupin and Cipla – to name a few.
While Asia and Europe are growing, the US is lagging. A pathway for market entry was only defined as part of the Affordable Care Act in 2010, six years later than in the EU.
Despite having several biosimilars FDA approved, very few have reached the market. This is because US regulations for proving similarity are far stricter. A ‘product by process’ mentality means that, unless a product is produced by the same methods as the innovator, it’s unlikely to be recognised and approved as a biosimilar.
There’s also a debate over how long exclusivity rights last in the US. Officially, it’s 12 years. However, a recent court case over Amgen’s arthritis treatment Enbrel, first approved by the FDA in 1998, gave them exclusivity rights until 2028.
Yes, Innovation should be rewarded – and a period of exclusivity is the only way to ensure that. However, 30 years is too long – especially when Enbrel biosimilars are now available in the EU and occupy 49% of the global market share.
There’s also the issue of education in the US. A study by the American Journal of Managed Care showed that more than half of physicians reported unfamiliarity with biosimilars. So, unless biosimilars can show significant improvements in safety or efficacy, many physicians won’t be able to use them.
Biosimilars will be crucial to shaping the biopharma industry - whether that’s pushing the rest of the industry to innovate, motivating competitive pricing or increasing accessibility to patients. However, the impact across biopharma will remain limited. That’s with the US biosimilar market facing so many issues, while still having such a large biopharma market share.
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