Biogen Director Shares Lessons Learned From EU Biosimilar Commercialization

When biosimilar adalimumab products launched in the European Union in October 2018, expectations were high with respect to levels of uptake and cost savings that were possible as AbbVie’s blockbuster Humira lost its patent protection in Europe. Since market entry, one of the biggest biosimilar winners in the adalimumab space has been Samsung Bioepis—a partnership between Biogen and Samsung BioLogics—and its biosimilar, Imraldi. To date, Samsung Bioepis’ product has seen the greatest success among biosimilar entrants in the key markets of the United Kingdom and Germany.

During the opening day of the SMi 10th Annual Biosimilars Conference, held September 25-26 in London, United Kingdom, Dan Cohen, Biogen’s regional senior director of biosimilars for the United Kingdom, Ireland, and the Netherlands, shared his experience with anti—tumor necrosis factor (anti-TNF) biosimilars in general, and with biosimilar adalimumab in particular, in the EU marketplace.

Samsung and Biogen’s partnership is responsible for 3 anti-TNF agents in the European Union, and Cohen explained that more than 170,000 patients with inflammatory diseases have now been treated with one of the partnership’s biosimilars, generating $1.8 billion in savings across Europe this year. “The proposition of biosimilars is actually paying dividends in the marketplace,” said Cohen.

In particular, the United Kingdom is seeing a substantial amount of those dividends, he explained. Since the introduction of biosimilars, 44% more UK patients taking are taking anti-TNF therapies as a result of cost savings that have expanded patient access.

“The UK does represent a bit of an icon, a bit of a beacon” in terms of how it has handled its transition to biosimilar anti-TNF agents, and “they’ve learned a lot from each of the various biosimilar introductions.”

One of the key drivers of biosimilar success for the UK market has been its top-town, payer-driven model. The National Health Service (NHS) has been ambitious both about creating and publicizing its targets for the use of best-value biologics, and “we have policy sitting behind the expectations” of biosimilar savings.

The use of gain-sharing models, in which hospitals share in the savings brought about by biosimilars, means that “there’s benefit to every single stakeholder involved” in the UK system through reinvestment, and healthcare providers are beginning to become more comfortable with using biosimilars as they gain more experience.

Another key to UK success has been NHS England’s multi-winner tendering process, under which multiple adalimumab suppliers were awarded lots of the market to ensure that there remains a plurality of supply in the United Kingdom. Having a variety of players in the market, said Cohen, is a crucial way to ensure that there are not supply disruptions that result in shortages or missed doses of adalimumab therapy.

Yet the UK experience with biosimilars has not been without its challenges, he added. The multi-winner tender itself brings with it the challenge of originator defense strategies; in allocating a share of the market to each adalimumab maker, including the reference Humira’s sponsor, AbbVie, the United Kingdom has found that, in some areas, the cost differential between biosimilars and Humira meant that the effort to switch to a biosimilar was not deemed worthy of the return. In these areas, which Cohen said includes parts of London, there has been “no movement, no uptake.”

Additionally, in the United Kingdom, there is a strong desire for patients to have a voice in the discussion about switching to biosimilars, and as patients who have switched to biosimilar adalimumab are now entering into their 6-month clinical reviews, there have been some complaints raised. Most of these complaints, he explained, are “because the patients felt done to” rather than consulted about the switch. Those centers that were particularly proactive about a “push model” of switching are seeing the most challenges with patients’ negative experiences of the switch, and developers and providers must learn from this experience.

In contrast to the United Kingdom, Cohen said, the Netherlands is only now beginning to see “green shoots of biosimilar policy creeping through” its very price-driven, highly price-sensitive market that features a group-buying model. In the Netherlands, where individual groups strike their own tenders with drug makers, AbbVie has dropped its prices for Humira substantially, and as a result, there has been very little uptake of biosimilar options.

“The Netherlands as a market is probably in danger,” Cohen said, because prices for biologics are dropping so low that biosimilar developers are beginning to have concerns about the market’s sustainability. Longer-term thinking, rather than short-term reliance on price drops, will be necessary if the market is to thrive.

Finally, Ireland, which has some of the lowest biosimilar uptake in the European Union, “must be an incredibly rich country,” Cohen said ironically, to have invested so little in its biosimilar ambitions to date.

Prior to 2019, Ireland offered very few to no mechanisms for gain-sharing and had no top-down policies to drive biosimilar adoption. This year, however, Ireland has begun to take some steps toward encouraging the use of the best-value biologics. The country has instituted a process in which it assesses biologic products on 13 criteria—including areas such as patient support services—to determine which offers the greatest value to the healthcare system.

Today, Ireland is beginning to treat more naïve patients with biosimilars first, and financial incentives to prescribe biosimilars rather than originators are driving increased interest in adoption.

Looking to the future, he said, developers should look to several key considerations. First, patient access, including patient experience and wraparound services that allow patients to feel comfortable with transitioning, should be prioritized. Second, “physicians want to have the choice of what they do, and they should have the choice. They’re physicians,” said Cohen. Prescribers should be free to decide what is best for their patients, but they should do so with the understanding that biosimilars are safe and effective options. Third, guaranteed supply is fundamental; if there are interruptions to supply, patients and physicians will lose confidence in biosimilars. Finally, with a view toward sustainability of the market, long-term thinking must be used to drive policy.

While there may be no such thing as a perfect system for biosimilar commercialization, said Cohen, the lesson derived from the UK, Dutch, and Irish experience is that “the right policy, the right process, and the right price will determine the right level of uptake.”