As the US prepares for the release of final guidelines in making biosimilars more available to the public, policy officials and decision-makers have the opportunity to learn from the European Union’s experience on the subject. Biosimilars have been around in the EU for nearly a decade, and many of the complications and discussions about biosimilars in the US can be improved and fast-tracked by following European models of testing, naming, guidelines, and interchangeability. To fully understand how the future of biosimilars in the US will benefit from the existing framework in Europe, consider how today’s biosimilar market in the US compares to the history and marketability of biosimilars in Europe.
History of Biosimilars in European Markets
In 2003, the EU created a legal pathway to the creation, approval, and marketability of biosimilars, reports the Generics and Biosimilars Initiative. The European Medicines Agency (EMA), the European equivalent of the US Food and Drug Administration, was charged with the approval of biosimilars for use in European nations. However, approval per country could only be determined at the national-level of each individual country by the country’s respective government.
Omnitrope was the first biosimilar to be approved by the EMA. However, 19 biosimilars have been approved for use in the EU. Originally, 21 biosimilars were approved, but two of them were removed from the listing due to unforeseen side effects. Additionally, the EU’s approach to approving biosimilars was successful applied to Inflectra and Remsima, which reiterated the success of using biosimilar production methods to produce complex, detailed molecules. As a result, the opportunity for more biosimilar approvals in coming years as drug patents expire will grow.
State of Today’s US Biosimilar Market
US discussion of biosimilars rests in a similar position to the EU after approval of Omnitrope. Drug manufacturers, physicians, pharmacists, and politicians expressed concern over how safe biosimilars could be when compared to reference products, as seen within commentary on EMA guidelines for biosimilars in the EU. However, as part of the Affordable Care Act, the framework for approval of biosimilars in the US was set forth, and several biosimilars, such as Zarxio and Enbrel have been approved. However, the FDA has not released any final rules for guidelines in the naming of biosimilar products.
European Market Considerations and Guidelines
Approval for biosimilars requires a demonstration of how two products maintain a similar nature, and comparability studies are required for each biosimilar, explains the EMA. To conduct this demonstration, the following eight points, among several others, must be addressed by the manufacturers and researchers:
- The standard generic approach to defining a chemically-derived medicine is not applicable to the productions means and capacity of biosimilars.
- Demonstration must evaluate whether any significant changes are made within the manufacturing process.
- Biosimilars must be similar in molecular structure and biological functionality.
- The potency of the biosimilar and route of administration must remain the same as the originating biologic.
- Deviations from the referenced product require justification and examination of how such deviations affect the treatment with the biosimilar.
- Biosimilars must be highly purified to remove any possible contaminated data from collection.
- If any intended changes exist for the purpose of providing an added benefit and advantage to the patient exist, they are allowed. However, they must adhere to all other guidelines for biosimilars.
- If a biosimilar is shown to be effective and safe in one setting, the data may be applied to other settings.
Naming of biosimilars in the EU has been relatively simple. Biosimilar names must adhere to and contain a reference to the International Nonproprietary Names (INNs) as defined by the World Health Organization. However, the naming of biosimilars in other countries, such as the US, which is currently under consideration by the FDA’s Guidelines, poses the possibility of inappropriate interchangeability indices for each biosimilar.
European Biosimilars’ Impact on Pharmacies, Payers, and Health Care Providers
Although biosimilars must undergo a two-stage approval process at the central level by the EMA and the national level for each country, many health care entities have continued to express concern over biosimilars, asserts the Generics and Biosimilars Initiative. Health care providers, pharmacies, and insurance companies want to ensure the post-marketing of a given biosimilar does not place marketability above patient satisfaction and safety. These are concerns similar to US healthcare entities.
Additionally, EU health care entities have doubts over the extrapolated indications of biosimilar testing. If a biosimilar has been tested and approved for an originating biologic, the biosimilar patient safety data and effectiveness may not be applied until the biosimilar has been investigated in each given regard. However, the extrapolation of data for these purposes is possible, explains the Generics and Biosimilars Initiative, if the following criteria is met:
- The biosimilar must be convincingly similar to the originating biologic in all gathered data.
- Clinical similarity can be shown for the biosimilar.
- The biosimilars safety profile maintains proper characterizing and does not provide for any exceptions to the possible contraindications of the originating biologic.
Producers of Biosimilars in Europe
In Europe, the primary manufacturers of biosimilars have been Big Pharma companies, such as AbbVie, Ratiopharm, Sandoz, Pfizer’s international conglomerate, Hospira, and more. However, some smaller, biotech companies have arisen to provide a place for competition within the growth of biosimilars in EU markets.
By nature, the production of biosimilars may cost more than the production of traditional drugs. Yet, biosimilar producers in Europe routinely apply discounts to biosimilar production of around 45 percent, explains Ben Hirschler. However, some discounts may be as high as 69 percent, such as the discount made by hospital tenders for a biosimilar to Remicade, a drug for the treatment of Crohn’s, rheumatoid arthritis, and other autoimmune disorders. Overall, the global market for biosimilars is expected to bring in sales in excess of $25 billion within the next five years.
European Impact on the Future of US Biosimilars
The FDA has followed an ad hoc policy for the naming, interchangeability, and approval of biosimilars in the US. In the coming months, the FDA is expected to release final requirements and guidelines for the naming of biosimilars, which may be retroactive to already-approved biosimilars. If the US follows the same pathway as Europe, biosimilars will become more rapidly available. Furthermore, a report on biosimilar cost savings, as identified by the Wall Street Journal, found savings from growing the use of biosimilars may reach $37.4 billion by 2020.
Ultimately, the cost of treatment approaches for differing ailments and subsequent costs to consumers, pharmacies, and other parties in health care settings will decrease. Although the US follows a slightly different path to biosimilars, the end result of EU and US measures to biosimilars remains the same: same money across the scope of health with a smaller impact on the finances and well-being of the average person.
Want to learn more about the future of biosimilars in the US market? Join us at CBI's 12th Biosimilars Summit, taking place January 24-25, 2017 at the Hilton Alexandria Old Town in Alexandria, VA.