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On the Eve of Humira's Patent Expiry, Europe Prepares for Biosimilar Adalimumab


October 16 marks European patent expiry for AbbVie’s blockbuster anti–tumor necrosis factor drug, adalimumab (Humira), and multiple competitors stand ready to launch their biosimilar products on, or shortly after, that date.

October 16 marks European patent expiry for AbbVie’s blockbuster anti—tumor necrosis factor drug, adalimumab (Humira), and multiple competitors stand ready to launch their biosimilar products on, or shortly after, that date.

Given the high cost of brand-name Humira, stakeholders are hoping for a substantial discount on these biosimilars relative to the price of the originator, and speculation has been swirling as to how low the list prices of the biosimilars could go. However, as Julie Maréchal-Jamil, director of biosimilar policy and science at Medicines for Europe, explained in an email to The Center for Biosimilars®, “Discounts are actually a poor indicator of the potential benefits to be realized by the healthcare community.”

Said Maréchal-Jamil, “In Europe, discounts do not mean the same thing across different national markets. In most countries, you can have a country-wide discount, followed by further discounts in regions, cities, or individual hospitals. This leads to a wide variety of discounts across the continent and even across countries.”

However, in Denmark, she explained, where current spending on 3 biologics—the brand-name adalimumab, trastuzumab, and rituximab—accounts for fully 6% of the nation’s pharmaceutical budget, stakeholders are keen to see strong competition.

What is clear, however, is that the European market sees reinvestment in healthcare services as a primary goal of a switch to biosimilar adalimumab. “In terms of actual benefit sharing,” Maréchal-Jamil said, “the EU national healthcare systems have an array of opportunities for immediate reinvestment in healthcare products and services but also looking at the looming and upcoming wave of innovation. The benefit sharing schemes, where they exist, have typically been devised so that patients in a given therapeutic area benefit from the biosimilar medicines choice.” These benefits may include additional nursing staff, educational programs, or supportive care.

However, while some markets may gain access to the adalimumab biosimilars and these associated benefits right away, companies may elect to bring their products to markets at different time points across the European Unio. Experience shows that larger markets, such as the United Kingdom, Germany, and France, typically see the first launches, Maréchal-Jamil said.

In the United Kingdom, in particular, dedicated efforts have been underway to make the most of savings provided by the arrival of biosimilar adalimumab.

Just last week, the National Health Service (NHS) published its final briefing on adalimumab, revealing that the NHS is prepared to begin using biosimilars beginning December 1, and that it issued invitations to biosimilar developers on September 19 to compete in the tendering process.

The tender strategy will award lots to 4 biosimilar products—assuming that Amgevita, Hulio, Hyrimoz, and Imraldi are all commercially available by December 1—and the size of each lot will depend upon offers received by the NHS. The brand-name Humira will also be allowed to issue a bid in the tender process. The companies will be notified as to which regions of the country they have been awarded on November 1.

“The strategy means that no supplier of adalimumab will be awarded the whole market but will have a strong incentive to offer their best price at the point of tender,” states the briefing document.

Warwick Smith, director general of the British Biosimilars Association, told The Center for Biosimilars® in an interview that “I think we will see a number of companies ready to launch at patent expiry,” and added that the United Kingdom, among EU member states, is likely to see some of the first launches, due in large part to lessons learned from past biosimilar experience.

“If you look at uptake of monoclonal antibodies since infliximab, it’s got faster each time,” said Smith, noting that the NHS has laid a solid groundwork to ensure that clinicians, health trusts, clinical commissioning groups, and patient groups are fully informed and involved.

As for how the NHS will handle switching patients to biosimilars of adalimumab, Smith indicated that some centers might choose to switch individual patients when they visit the clinic for their next 6-month follow-up appointments (rather than switching all of a center’s patients at once). Such an approach might help to ease the burden on clinical staff who must educate patients about the change of therapy.

As for patients’ feelings on making the switch to a biosimilar, Smith indicated that, with biosimilars past, patients have been engaged more and more effectively over time. “The vast majority of patients have been supportive of switching to the biosimilars,” he said, given the fact that benefits from cost savings directly benefit patient care in the UK health system.

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