POCP Blog

By Tony Schueth

Biosimilars now are being introduced in the United States and are expected to rapidly become lower-cost, mainstream treatments for a range of chronic diseases, including cancer, rheumatoid arthritis, diabetes, multiple sclerosis and kidney disease. In response, it’s not too soon for stakeholders to work on making biosimilars safe and useful within the parameters of today’s healthcare system.

Drivers. There are several reasons why stakeholders — health information technology (healthIT) firms, standards developers, electronic health record (EHR) vendors, physicians, and pharmacy systems —  need to pay attention to biosimilars sooner rather than later. One is cost savings. RAND estimated savings from using biosimilars at $44.2 billion over 10 years. This will stimulate adoption as payers and government entities are looking for ways to reduce costs while providing therapeutic alternatives to the escalating numbers of the chronically ill. In addition, many leading and expensive biologics are facing a “patent cliff.”  This means their patents will expire in the near future, which will open the door for the launch of related and lower-cost biosimilars. There also is an active pipeline of some 80 biosimilars under development worldwide, so availability will create demand.

With these issues in mind, the Point-of-Care Partners team (POCP) has developed a series of blogs focusing on the impacts of biosimilars on various stakeholders and the status of state biosimilar substitution legislation. This blog is the first in the series. It provides some basic background on biosimilars and their use.

What are biosimilars? The advent of biosimilars will require stakeholders to adjust to new concepts.  Definitions are an example.  Biosimilars are “follow-ons” of previously licensed biologics or reference products, which are made from living organisms and whose cells may be manipulated to treat specific diseases. According to the Food and Drug Administration (FDA), biosimilars are similar to but not identical copies of the originator biologic, “notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product.”

Why are they different? Biosimilars are inherently very different from conventional drugs in several ways, including their composition, administration, manufacturing and regulatory oversight. For example, biosimilars:

• Are made from living organisms. Most biological products are more complex in structure and have larger molecules or mixtures of molecules than conventional drugs (also called small molecule drugs). Conventional drugs are made of pure chemical substances and their structures can be identified.  Most biosimilars, however, are complex mixtures that are more difficult to identify or characterize.
• Have different manufacturing processes. As a result of their complex makeup, biosimilars are highly sensitive to manufacturing and handling conditions. These issues make biosimilars more difficult to produce than chemically-synthesized, small molecule medicines. Because no two biologic medicines are identical, stakeholders are honing in on postapproval safety monitoring, which will detect potential differences in safety signals between a biosimilar, its reference product, and other biosimilars.
• Have different regulatory processes. The government has special regulatory processes that address the unique properties of biosimilars and associated patient safety concerns. This results in different regulatory approval pathways, manufacturing oversight, and pharmacovigilance. States are already on board with enacting — or considering enacting — legislation pertaining to the substitution of biosimilars over the drug that was originally prescribed.
• Have different locations for administration. Biosimilars generally are Infused or injected at physician offices, hospitals clinics or even patients’ homes.
• Are not generics. Unlike generics, which have simple chemical structures, biosimilars are complex, “large molecule” drugs that are not necessarily identical to their reference products. In addition, biosimilars made by different manufacturers will differ from the reference product and from each other, making each biosimilar a unique therapeutic option for patients.

What does this mean? All of this means that stakeholders will need to better understand biosimilars and adapt technologies and workflows to their use. These will be discussed in depth in our biosimilar blog series.  But just to whet your appetite, consider the following:

• Standards already exist to capture much of the information that would be useful in biosimilar tracking. How should they be modified to accommodate biosimilars? What about the use of different standards, such as the ones used overseas?
• EHRs will need to make many changes to accommodate the unique aspects of biosimilar dispensing, administration and outcomes. EHRs must be able to comprehensively record data on what was prescribed but ultimately administered or dispensed for an individual patient. Modifications will be needed for tracking adverse event reports in various administration locations. Adaptations will be needed for prescriber usability.
• Physicians will need to be educated about biosimilars and better understand the patient safety issues involved. They will need to adapt to new work flows for prescribing and prior authorizations.
• Pharmacy systems will need to build biosimilars into their drug utilization review programs; accurately capture details about what was dispensed versus what was prescribed. Specialty pharmacies will also need to understand substitution rules for the states they serve and develop the required communications to physicians to keep them informed when a substitution occurs.
• Pharmaceutical manufacturers also need to keep up with changing state laws concerning substitution. In the event of a manufacturing issue, the ability to track which manufacturer and lot number might be causing poor outcomes or adverse events will be critical.

Let us know if we better help you understand biosimilars and their impact on your organization. For starters, check out our Regulatory Resource Center, which makes it easy for you to keep up with state and federal regulatory actions. In the meantime, stay tuned for the remaining blogs in our series on biosimilars.

• Post Categories
• Biosimilars
• ePrescribing
• Patient Safety