An understanding of biosimilars will be essential for patient consults and education.
BIOSIMILARS ARE THE HOT TOPIC in the health care marketplace. Prescribers, nurses, regulators, payers, and even health care consumers are immersed in continual dialogue about the key role biosimilars will play in the future of health care, as they can help address the evolving needs of health care stakeholders.
But what about pharmacists? A critical bridge in the health care continuum, pharmacists are charged with educating patients, addressing their concerns, and navigating the complexities of patient reimbursement. It is imperative that the pharmacy community be part of the biosimilars conversation, so they are equipped to engage with and educate patients about these new medications.
High-Stakes Challenges for Pharmacists
In the United States, pharmacists dispense over 4 billion1 prescriptions annually. As part of that process, the pharmacist must interpret the physician’s prescribing orders and understand the medication’s indication and instructions for appropriate use.
Biosimilars will offer additional versions of many frequently prescribed biologic medications, requiring a pharmacist to have a solid understanding of the available treatment options. It is important to ensure the pharmacy community has the information it needs to distinguish between biosimilars of the same reference product and, along with the patient’s physician, address patient questions and concerns regarding their medication.
An understanding of the science and manufacturing of biosimilars is a key foundational element of overall biosimilars education, and will help ensure that the patient—pharmacist relationship continues to be one rooted in trust and affirmed by the pharmacist’s commitment to appropriate patient care.
The Science of Biosimilars
The concept of “totality of evidence” refers to the extensive comparative analytical (structural and functional), nonclinical, and clinical data required to establish biosimilarity, all of which are considered by the FDA in evaluating an application for a biosimilar.
This is a critical, cornerstone concept in building an understanding of biosimilars, as it speaks to the different paradigms for developing and regulating biologic products. Regulatory guidance states biosimilars must have high similarity to the reference product, meaning that there are no clinically meaningful differences in terms of safety, purity, and potency.
Slight differences between biosimilars and their reference products are expected due to the inability of manufacturers to exactly replicate a therapeutic protein, and are permitted, provided the variations do not produce any clinically meaningful differences. To generate this evidence, biosimilars require preclinical proof points and clinical data to demonstrate they are highly similar to the original biologic.
Small-molecule drugs can be more easily replicated, whereas the manufacturing of biologics and biosimilars is highly specialized. Rigorous controls and methodologies are critical, as small changes in manufacturing may alter the structure of the protein, which, in turn, may impact the efficacy of the molecule.
Since biologics are large molecules, the immune system recognizes their presence and its response can be affected by variations in those molecules caused during the manufacturing process.
The Biosimilars Landscape
Regulators, policy makers, and physicians are working to solve many of the key challenges in the biosimilars industry. By focusing their education on the ways these challenges affect patients, the pharmacy community can be better equipped to help optimize patient care.
At this time, there are 3 important topics for pharmacists to understand: naming, extrapolation, and interchangeability. The naming of biosimilars is a popular topic of debate: how should biosimilars be distinguished from each other and the reference product?
Understanding the application of International Nonproprietary Names can help pharmacists assure patients they are receiving the treatment prescribed by their doctor. Extrapolation is the approval of a biosimilar for an indication held by the reference product but not directly studied in a comparative clinical trial with the biosimilar.
With biosimilars, extrapolation is possible based on the overall evidence of similarity. Pharmacists can benefit from understanding the extrapolation of biosimilar indications, as familiarity with the similarity, safety, and efficacy evidence is important for patient consults.
Interchangeability means that a biosimilar can be substituted for the innovator reference product without the involvement of the health care provider who wrote the prescription. This is also a key concept that pharmacists will need to understand, as they will need to work closely with physicians to ensure that if a patient is switched to a biosimilar, they will still achieve the same clinical benefit as if they remained on the reference product.
Pharmacists Are Partners in Educating Patients
Given the rapid emergence of biosimilars and the broad spectrum of related conversation, what are the key takeaways for pharmacists looking to further their understanding of biosimilars?
JAVIER COINDREAU, MD, is vice president of global medical affairs for Pfizer Biosimilars.