What are biosimilars? How biosimilars differ from biologics in cost & benefits

There are often a variety of factors which influence physician choice of new products and therapies, including the influence of the pharmaceutical industry, doctor and patient characteristics and of course knowledge of the drug itself.¹ It’s natural therefore for physicians to have questions and concerns about biosimilars as a novel therapy.

Derek Burns and Tim Ho, clinical specialists at McKesson, share their insights on biosimilars and discuss their expert knowledge of these new products.

“Biosimilars are safe and effective for patient care, and many physicians have successfully implemented the use of biosimilars within their practice,” Burns notes. The FDA itself confirms this, noting that FDA approval of a biosimilar is based on clinical analysis, toxicity assessment and other rigorous studies.²

What are biosimilars?

“A biosimilar is a biological agent that is highly similar to and has no clinically meaningful difference from an existing approved reference product,” Ho explains.

Though minor differences may exist, they have been carefully evaluated to determine that they meet FDA’s high approval standards.

Ho says that “a manufacturer must demonstrate that the proposed biosimilar product is highly similar through analyzing the characteristics of the product, such as purity, chemical identity and bioactivity. The second major attribute is it must display no clinically meaningful differences in terms of safety, purity and effectiveness through pharmacokinetic and pharmacodynamic studies.”

In sum, similarity of the product and the lack of significant clinical difference are both important characteristics of biosimilars.²

Biosimilars may help the aging population in the United States manage a wide variety of chronic conditions, including a number of chronic conditions. For example, Renflexis, Inflectra and Avsola have each been approved to treat both adult and pediatric Crohn’s disease, as well as adult and pediatric ulcerative colitis.³

What’s the difference between biosimilars and biologics?

There are some important differences between biologics, like Remicade, and their biosimilar counterparts.

The FDA states that though a biologic is a “complex drug created from living cells,” it differentiates these drugs from biosimilars, which, again, are products that have little or no medically meaningful difference from biologic agents.⁴

“We cannot fully understand the difference between biosimilars and biologic agents without defining what a reference product is. A reference product is simply a single biologic agent that is already fully approved by the FDA, to which a biosimilar is compared,” explains Ho. This is the same definition given by the Drugs.com.⁵

Ho defines a biological agent as one “derived from a category of products that are generally made up of large and complex molecules. Unlike generic products, these products are produced through biotechnology in a living system. Because of their origins within a living system, there are inherent variations that can occur as a result of the manufacturing process that do not exist in small molecule chemically synthesized drugs.”

Due to the complexities associated with biologic agents, they can be difficult to fully characterize. Ho says that “slight differences between lots of the same biological product are normal (as long as they fall within an acceptable product variation level).”

The FDA and manufacturers have implemented robust strategies to ensure that biological products have consistent clinical performance.

The approval process is another important difference between biologics and biosimilars. Ho goes on to note that “The 351(a) regulatory pathway is typically the method of approval for a biological agent seeking first-time approval.”

In the case of biologics, the main purpose is to “determine the clinical effect for each indication”; the majority of this pathway is spent in clinical phases I, II and III. In contrast, the main purpose of the regulatory pathway for biosimilars is to determine their similarity to the reference medication; most of this pathway is spent in the analytical and preclinical trial phases.²

Clinicians who may be new to biosimilar products may be concerned about their clinical effectiveness, but in fact the testing for biosimilar is thorough and it must be proven that they produce the no meaningful clinical differences from the reference product.²

The cost-benefit analysis for using biosimilars

The use of biosimilar drugs can save money for both patients and providers. Increased affordability of the biosimilars can have a meaningful impact on the healthcare system, and it’s estimated that their use can improve access to these therapies for around 1.2 million patients and save them approximately $100 billion over five years.⁶

The economic impact of the increased use in biosimilar products has the potential to be significant. According to an article in Rand Health Quarterly, it’s estimated that use of biosimilars (as opposed to biologics) will save around $54 billion between 2017 and 2026.⁷

Expense is definitely on the minds of groups like the Onmark® GPO, a division of McKesson composed of experts who work with physicians to help control drug costs and maximize savings for both patients and providers.

Best practices for adopting biosimilars

If you and your clinic are considering the adoption of biosimilars, you may be wondering about how to do that. Here are some best practices to be aware of as you consider this:

• Take a multi-disciplinary approach and include all team members in the decision-making process; it helps for all stakeholders to understand how your clinic will go about adopting these new products
• Appoint one member of the team to lead the conversion process
• Understand both the effect the biosimilars will have on your patients and also how your primary payers will reimburse these products; it’s important to check their formularies to see if biosimilars are included
• Educate your staff on biosimilars so that they, in turn, feel comfortable educating patients and answering questions that they might have about these new therapies

These practices can help make the adoption of biosimilar products a smoother process for your clinic.

Consider biosimilars in your practice

Biosimilar products are therapies that have similar therapeutic value and potency as their biologic counterparts but at a different price point. These new emerging therapies will be important to gastroenterologists, rheumatologists and other specialists, particularly because of the biosimilar’s ability to help manage significant chronic conditions like rheumatoid arthritis, Crohn’s and ulcerative colitis, but at a lower healthcare cost to both patients and providers.