Booming Biosimilars

Regulatory changes are paving the way for speedier access to biosimilars in the US, while gain-share agreements are driving strong adoption rates in Europe.



Both patients and biosimilar manufacturers received a major boost recently when the US Supreme Court ruled that companies no longer needed to wait six months after FDA approval to launch their products.

While Europe has been ahead of the curve in adopting biosimilars, the global market is exploding – one prediction places it at $10.9 billion by 2021 – and this latest ruling means patients in the US too will gain earlier access.

The FDA has been “on a roll” recently, says Alpna Seth, Senior Vice President and Head of Biosimilars at Biogen, with the rapid approvals of three major anti-TNF [tumour necrosis factor] biosimilars adding to the ever-growing medicine cabinet portfolio of less expensive biosimilar medicines.

“The US is catching up and moving very rapidly, although intellectual property is a big aspect in the US that needs to be sorted,” she says, adding that Europe has more than 10 years’ experience in dealing with these kind of biotech medicines.

The main catalyst for change has been cost, she says, as the increasing use of expensive biologic therapies continues to have a major positive impact on national healthcare budgets and thus governments are increasingly embracing biosimilars.

Adoption rates in Europe have not necessarily been as expected and fluctuate significantly from country to country, says Seth. “The UK is a significant and influential market and one would have thought it would have had a slow uptake, but the opposite has been true. In fact, there are many hospitals where nearly all patients have been transitioned from Enbrel to [biosimilar] Benepali, with good results.”

This rapid uptake has been driven by several factors, she adds. “In the UK, NICE and the NHS have been proponents of biosimilars, and Benepali is viewed favourably. Also, in the UK, we see clinical commissioning groups working with hospitals, Trusts, physicians and patients, a real multi-stakeholder approach. We know now that the more multi-stakeholder the approach is, the better the uptake and higher the confidence in biosimilars.”

Another driver of switches to biosimilars has been the adoption of ‘gain-share’ agreements. “In the UK, access is not always a given. Hospitals are stretched and the entire system is under pressure, but what has really taken hold is the idea of gain share because it is a win-win – patients get access and physicians benefit because the savings are invested back into the hospital in order to improve patient care.”

Looking beyond the UK to the rest of Europe, the absence of an incentive can be a barrier to biosimilar adoption, says Seth. “There are physicians who are less inclined to adopt biosimilars; they are happy with what they have and the system provides no incentive, so they remain with the status quo. This also happens when there are no reprimands in place.

“In some places, where the systems are so stretched, they could really do with the savings that biosimilars bring, and it is a pity that they are not benefiting,” says Seth.

Annual spend on the three anti-TNF drugs that have biosimilars available is close to $10 billion in Europe alone. Biogen is continuing to launch etanercept biosimilar (Benepali) and infliximab biosimilar (Flixabi) across Europe, while their partner Samsung Bioepis’s application for biosimilar adalimumab is currently under review following a CHMP positive opinion.

“For patients with chronic diseases, we need to have quality supply that is uninterrupted, and that is something we focus on a great deal. Our products are manufactured in Europe for patients in Europe. We believe we can compete even if the space is crowded,” she says.

Looking to the future, Seth believes the clinical requirements for biosimilars may potentially diminish. “We are not there yet, particularly for the more complex biologics, but I see the guidelines and regulatory requirements evolving over time.”

Yet, generating real-world evidence for biosimilar use is crucial. “This evidence continues to increase the level of confidence and give us new insights. It can be used in value-based agreements and contracts, and overall it is a positive driver, as we can show high levels of acceptance and high levels of adherence. It is also an opportunity to demonstrate the value that it offers to patients and each health system.”


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