Experts Share Their Experience of the Global Biosimilars Market

The Biosimilars Commercialisation Summit 2019 is held under Chatham House Rules, which stipulate that speakers cannot be identified.

This week, stakeholders from the legal, business, clinical, and development fields of the biosimilars landscape gathered in Amsterdam, the Netherlands, for the Biosimilars Commercialisation Summit 2019, a meeting dedicated to global issues in biosimilars market access. During the meeting, experts from around the globe discussed their experience with biosimilars and the opportunities and challenges that lie ahead.

The United States

Participants generally agreed that the United States is far from where it wants to be in terms of its biosimilar uptake to date, and that fact has much to do with the relatively few products that have launched compared with the 19 products currently approved by the FDA under the biosimilars pathway. Legal hurdles, participants acknowledged, were largely to blame.

A representative from the United States explained that, in his view as an attorney, the issue of patents is “the unfortunate 900-pound gorilla in the room,” and he explained that, while the past year has not had many landmark court decisions that impact the biosimilars industry, an ongoing suit between AbbVie and Boehringer Ingelheim (BI) over adalimumab brings the legal issues present in the United States into clear focus.

The litigation involving AbbVie and BI is notable, he indicated, because so many other biosimilar adalimumab developers have reached settlements with AbbVie. Not only is BI the only developer who has proven willing to forge ahead with its litigation in the face of AbbVie’s numerous patents, the case is also notable because it makes claims related to the sheer number of patents that AbbVie holds. Among the issues that BI has raised, he indicated, is the fact that, of the 75 patents at issue in the case, only 1 had actually been granted at the time of the original Humira approval, and the rest were amassed later.

BI is also the only biosimilar developer that has publicly announced an intention to seek an interchangeable designation for its product, and, said the attorney, if interchangeability is eventually granted for Cyltezo, it could be a game-changer. “They obviously see that it’s worth the effort,” he said, to gain 6 months of exclusivity in the US market, and he suggested that BI must feel that its clinical studies show that an interchangeable designation is possible.

Hours after he spoke, however, AbbVie and BI announced a settlement of the litigation, under which BI will not be allowed to market Cyltezo in the United States until July 2023. BI will pay royalties to AbbVie on its sales.

Mexico and Brazil

A business expert from Latin America also weighed in on the issues at hand in his region, and he spoke to the developing markets of Brazil and Mexico, which encompass more than 300 million people.

He explained that, while much of the conversation about biosimilars in the United States and Europe relates to evidence-based medicine, “those are not the items we’re discussing in Latin America.” Instead, “we’re discussing inventory-based medicine,” he said, highlighting the fact that market access remains a challenge.

For biosimilar developers seeking to bring their products to Mexico, he explained, there are no private-sector concerns to address, but companies do have to grapple with a range of public institutional clients.

He noted that Mexico uses 4 main channels to provide care: the Mexican Institute for Social Security, which provides care to 55 million workers and spends US $1.8 billion per year on medicines; the Mexican Civil Service Social Security and Services Institute, which provides care for 17 million federal workers and spends $800 million each year; Pemex, a Mexican oil company that spends $57 million each year for its workers; and Seguro Popular, which spends $1.1 billion each year to cover those without formal jobs.

In addition to addressing the needs of each of these groups, across 33 states and more than 2000 municipalities, nontraditional drug distribution channels also exist. He said that approximately one-third of Mexico’s national market for drugs comprises non-audited channels, such as the resale of pharmaceuticals by third parties in remote areas of the country that are not well served by the healthcare system.

Brazil, too, is a large yet highly decentralized market, with 57 states and more than 5000 municipalities that must be addressed individually. It is not easy, he explained, to identify which of those thousands of local areas will be the ideal fit for a biosimilar developer’s business model.

However, Brazil’s regulatory authority signed an agreement in May 2018 that will reduce the timeframe and the number of steps required to allow drugs to be imported into the country, and will reduce taxes on pharmaceuticals, making Brazil an increasingly attractive market. Additionally, Brazil can act as a gateway to market access in other Latin American countries, including Columbia, Argentina, Peru, Uruguay, and Paraguay.

For those developers seeking to commercialize biosimilars in these countries, he explained, it may be useful to consider partnering with a local business—especially to help with understanding the system of taxation—before setting up business as an independent company in the region.

Denmark

Finally, an industry association representative from Denmark discussed how his country has achieved health system savings through biosimilars, and he looked to the future of the Danish biosimilars market.

The Danish system, he explained, has a unique structure: 5.7 million people, living in 5 regions, have access to regional hospitals that provide free healthcare and free medicines. Regions agree on financial frameworks with the government annually, and each region is responsible for complying with the budget.

The Danish tendering system is operated by Amgros, an entity owned by the Danish regions. Amgros must strike a balance between security of supply and price via its tenders, which are typically held once per year and are on a winner-take-all system that has generated “huge rebates” through the use of biosimilars.

Finally, the Danish Medical Council (DMC), established in 2017, makes scientific assessments and advises Amgros. The DMC has been active in putting forth strong recommendations on biosimilars, indicating that they can be used in all patients, except in very specific individual cases.

The coordination of efforts among the regions, Amgros, and the DMC has meant that, 3 weeks after biosimilar adalimumab reached the country, it gained 90% uptake and “Humira has been totally wiped off the Danish market.” He noted that, while AbbVie offered a 78% discount on Humira, that price drop was not enough to win the tender.

The quick uptake of biosimilar adalimumab reflects similar experience with infliximab; within the first year of availability, the biosimilar gained 90% of the market and the price of the therapy dropped by 68%. Biosimilar etanercept also saw 90% uptake within a year, which produced a 54% reduction in etanercept’s price.

“The Danish way,” he said, is to base decisions on science, use biosimilars from the first day of availability, encourage close stakeholder cooperation, and provide broader access to treatment. “Whether that’s a miracle or common sense, I’ll leave you to decide.”

Of course, Denmark’s path cannot be directly reproduced by other countries with dissimilar systems, he indicated, but elements of its plan can be adapted for use elsewhere. One key recommendation for other nations to use, he said, is to provide unbiased information to patients, who have been, he said, targeted by “you know who, feeding information to the patient organizations” and raising concerns among patients. The European Medicines Agency and other national organizations can play a role in making sure that science, and not misinformation, prevails.

Considering the future of the Danish biosimilars market, he indicated that there do remain open questions about sustainability. While brand-name infliximab, rituximab, trastuzumab, and adalimumab were responsible for about 10% of Danish hospital spending before biosimilars, the drugs coming through the pipeline are not blockbuster products.

He also indicated that multiwinner tenders, which encourage more developers to stay in the market with their, could be a means by which to encourage a robust biosimilar marketplace for Denmark, saying “What can look like a huge success in the short term might not be a huge success” if it does not remain sustainable for the long term.