Report Points to Room for Improvement in the European Biosimilars Market

US stakeholders often refer to the European market for biosimilars as a success story that the United States should emulate. However, while Europe has, on a broad level, achieved good biosimilar uptake and strong savings, individual countries’ experiences with biosimilar differ significantly, with variable uptake, differing policy environments, and country-specific challenges.

A new KPMG report, commissioned by generic and biosimilar trade group Medicines for Europe, identifies some of the features of drug procurement in hospitals in different countries in Europe, explains how they impact biosimilar uptake, and gives recommendations to help biosimilars play a role in the strong—and growing—need to reduce spending in health systems.

First, different European countries approach the matter of procurement and price negotiations differently. In Belgium, for example, drugs have a relatively long time to market (11 months) for approved products. The government sets maximum prices for all medicines, and biosimilars are typically priced via eternal reference pricing. A mandatory discount of 7.5% off the reference biologic is in place, but discounts are typically more than 30.0%. For biosimilars, tenders (typically winner-take-all and 18 months long) are performed by hospitals, and they may be separate for new patients and currently treated patients.

The report’s authors note that an important enabler of biosimilars in Belgium is its system of prescribing quotas for low-cost therapies, but the fact that the quotas encourage “low-cost” therapies generally, rather than generics or biosimilars specifically, has led to low market penetration. Other barriers include the fact that the tender system includes criteria that may have little to do with price, such as delivery speed.

Unlike Belgium’s lengthy time to market, Germany has relatively quick access to drugs, and all drugs are, in principle, reimbursed. Hospitals can procure medicines individually or in groups, and they negotiate with manufacturers directly. A key enabler of biosimilars in Germany is the attitude of providers; the report indicates that physicians and pharmacists typically have a positive view of biosimilars and no longer voice concerns about safety and efficacy.

In France, where reimbursed drugs are subject to price negotiations between the government and drug makers, hospitals rely on tenders, typically conducted in groups. Tenders for new patients and currently treated patients are conducted in a single lot, typically with one winner. When the first biosimilar enters the market, a 30.0% discount for the reference establishes a maximum price; during tendering, companies can offer lower prices.

France aims to increase the levels of biosimilars prescribed in hospitals by 15.0% in the next 3 years, and prescribing drugs by using the international nonproprietary name, says the report, could be an important driver for biosimilar adoption. However, timeframes between tender procedures and first deliveries are often short, which makes supplying biosimilars in a timely way challenging.

Such a variety of methods for addressing biosimilars has led to a wide difference in biosimilar volume in hospitals across Europe; according to the report, which draws on IQVIA data, a simple average of hospital biosimilar volume in March 2019 shows that Denmark has achieved 63.0% overall biosimilar volume, with the United Kingdom coming in at a distant second at 45.0%. Germany had 40.0% biosimilar volume, while France had 34.0%, and Belgium tied with Switzerland for last place among the countries studied at just 14.0%.

In order to improve these numbers, says the report, European countries can take a number of steps to make the marketplace more conducive to biosimilar uptake. The report provides 9 recommendations for increasing the use of generics and biosimilars:

• Move away from using lowest-bid procedures and, instead, take qualitative elements, like a proven track record of supply reliability, into account.
• Set accurate volume estimates to guarantee supply, enabling manufacturers to have better predictability.
• Award tenders to multiple winners to encourage multiple manufacturers to remain in the market and to ensure supply.
• Reopen tenders after the entry of the first multisource medicine in order to foster competition.
• Streamline the tender process by requiring essential information and digitizing procedures.
• Create guidelines and informational campaigns to increase awareness of biosimilars.
• Create incentives for biosimilar use that look to long-term sustainability by implementing target agreements and biosimilar use quotas.
• Draft national or local guidelines on switching.
• Implement benefit-sharing methods that allow biosimilar savings to be reinvested in the healthcare system.