Tony Hagen is senior managing editor for The Center for Biosimilars®.
Some European markets are more formidable than others with regard to complexity and getting biosimilars established, but there are good places to start, Jonathan Sweeting, head of Europe for Samsung Bioepis, explains.
As Samsung Bioepis moves ahead with the launch of its recently approved bevacizumab biosimilar Aybintio in Europe, it will have to contend with diverse individual market challenges within the European community. For starters, however, there are a few markets where the on-ramp gradient is relatively smooth: Germany, the United Kingdom, and the Nordic countries (eg, Denmark, Sweden, Norway), said Jonathan Sweeting, head of Europe for Samsung Bioepis, in an interview with The Center for Biosimilars®.
In those countries, “You can launch pretty much immediately with minimal additional effort, certainly from a pricing and reimbursement perspective. Spain and France tend to have a slightly more formal pricing and reimbursement review that can take a few months,” he said.
Sweeting discussed the launch of Aybintio, coronavirus disease 2019 (COVID-19) and its effects on regulatory and marketing activities, and Samsung Bioepis’ outlook on European markets for biosimilars.
In partnership with Biogen and Merck, the Incheon, Republic of Korea—based company already is well experienced with the European market. They have a strongly performing portfolio of biosimilars that includes an etanercept (Benepali), which competes “head to head in terms of market share” with the originator product Enbrel; an infliximab (Flixabi), which has achieved leading market positions in some European countries; a trastuzumab (Ontruzant), which now leads the trastuzumab biosimilar pack for market share in Europe; and an adalimumab (Imraldi), which competes successfully in a crowded market of multiple other adalimumab biosimilars, Sweeting said. “We hold the number 2 position from a biosimilar perspective, and we continue to see great growth potential.”
Not a Collective
Outsiders often consider Europe as a kind of “collective” when it comes to bringing products to market, but that’s far from the truth, Sweeting said. Each country is its own market and within that market there are further divisions, he said. Country-by-country policies, regulations, and strength of competition each play a role in how successful a product launch is going to be.
Tenders, or bidding processes for drug acceptance on formulary, may be tied to regions within a country or tied to divisions within a health care system, Sweeting noted.
Some supply contracts within European countries may involve negotiated agreements with multiple manufacturers. “In some cases, if you’re a later entrant onto the market, you can approach a buying group that may have already entered into a contract and make a counter proposal, and they may or may not consider it.”
“The reality is…on a day to day basis, we’re constantly having to adjust and operate in a way that’s in keeping with the specific market that we’re talking about,” Sweeting said.
Aybintio is not the first bevacizumab biosimilar to arrive in Europe; however, “We consider ourselves to be in the first wave,” Sweeting said. “In general, we see a good opportunity to compete with that first wave.”
Coming in at a Discount
Samsung Bioepis is not disclosing the discount from reference product it intends to offer for Aybintio in Europe. But Sweeting said originator pricing for a 400 mg vial of bevacizumab currently stands around $850 and biosimilar discounts in Europe can be sizeable.
The various policies in Europe for setting product reimbursement combined with heavy competition have been viewed as pulling support out from underneath prices. This is a fact of life in biosimilar markets as it is for other products, Sweeting notes.
“Of course, you‘ll find that various pricing and reimbursement authorities and health care systems across Europe…will mandate certain price reductions at different points in time in a fairly structured way,” he said. “The contracting or tender-based markets that we’re competing in of course are mainly driven by natural competitive forces, and some companies choose to compete in certain tenders and not in others, with a view to maintaining slightly higher prices. Other companies will compete everywhere and perhaps slightly differentiate their pricing approach dependent upon the size of the tender or the contract that they’re working on.
“You do also find the prices come down more quickly in some therapeutic areas and through some channels, often in the hospital-based channels—we tend to find [this happens] more so than they might do in the retail channel. Ultimately, this comes down to how many products are on the market, how quickly they get there, and ultimately, the internal decision making within the manufacturing community as to how quickly they want to drive their own uptake in the market,” he said.
Biosimilar Education in Europe
In the United States, it’s often lamented that biosimilar education is not as robust as it could be, and for that reason patients and physicians are not as well informed as they should be about the safety and efficacy of these agents, contributing to low levels of uptake.
The situation in Europe, for the most part, is the reverse, Sweeting said. “It’s for that reason that the market is actually so much more developed than it is in other parts of the world. The uptake over quite an extended period of time has been pretty significant. That said, there’s always more you can do.”
Sweeting said the company has regularly been involved in educational meetings “where we’re explaining what biosimilars are, how they’re produced, and the quality control mechanisms that we have in place.” In the Nordic countries, especially, biosimilar awareness is high and “there’s actually minimal amounts of work needed at the physician level—the system really drives the uptake,” he said.
In response to a query whether the European regulatory approval process for biosimilars has slowed down because of the COVID-19 pandemic, Sweeting said it appears not.
“What we have seen, day to day, and through our work with our commercial partners, is that there have been some contracting processes or issuance and decision-making of tenders in particular countries that have been delayed to some extent. Regulatory-wise, we haven’t seen a delay, certainly, for the bevacizumab cycle that we’ve just been through.”
Are Digital Sales Here to Stay?
As the worldwide business community has gotten accustomed to low-transmission safe practices during COVID-19, the door has reopened to actual physical interaction—based sales promotions, but only slightly, Sweeting said.
“Most of Europe has had to stay remote in their interactions with customers, and that is still primarily the case now. We have seen some opening of face-to-face contact and access in certain parts of Europe—Germany is one we’ve seen a bit of movement in, and in France and Italy from a major market perspective, but they are the exception rather than the rule at this stage. And there’s to some extent a second wave [of COVID-19] hitting many countries around the world,” Sweeting said.
“I personally think that the remote interaction that is or has become the norm over the last 6 months or so will continue to be the case, and that is something that, for sure, our partners are heavily reliant upon as well.”