Main Barriers to Biosimilars uptake

When talking about improving access, the first question to be addressed is: What are the barriers and obstacles that are making this access impossible to reach?

In the following lines, you will get a brief insight into the important keynotes from Professor Daniel F. , (Regional Medical Affairs Director - Sandoz )

Biosimilars LatAm - Brazil 2022 - Panel: Greater Access to Safe and Effective Life-saving Medications.

"From my experience, the main barriers to biosimilar uptake can vary depending on the stakeholder perspective. "

Daniel S. Freire, M.D., Ph.D.

Main barriers to #biosimilars uptake:

1. Healthcare professionals

From the point of view of healthcare professionals, the main challenge is related to the education on biosimilar conceptualization and switching. Biosimilar education should be stimulated and incorporated into the curriculum of all medical, nursing, and pharmacy schools.

2. Patient’s perspective

The reassurance of the safety and efficacy of biosimilars is a key aspect of improvement. As it should be, this information is gained from trusted health care professionals.

The lack of education from the health care providers is obvious and can affect the information received by the patients. Mainly when it comes to difficulting the decision-making process due to misinformation that naturally leads to mistrust and a general lack of confidence.

3. Payors and hospitals

Regarding payors and hospitals' policies and reimbursement, rules should prioritize biosimilars

Conceptual Challenges, Misinformation & Opportunities

Conceptual challenges

• Product variability (batch-to-batch, manufacturing changes)
• “Abbreviated” licensure pathway
• The totality of evidence (foundation is analytical, confirmation is clinical)
• Clinical data
• Extrapolation

Types of misinformation

• Incorrect information about biosimilars. “EU pharmacovigilance of biosimilars is inadequate and patients cannot be confident about the reliability of these data”
• Correct information, but out of context. “there is no interchangeable infliximab biosimilars available in the USA”
• Incomplete information. “biosimilars are not identical to the reference biologic”
• False narrative. “safety and efficacy of switching is still controversial”
• Negative message framing. “non-medical switching” is not the same as “switching to a biosimilar” ?

*The ominous cycle of biosimilar unawareness

Opportunities

• The knowledge gap and the misinformation cannot be ignored.
• Positioning of health authorities (FDA, US-FTC, and ICMRA).
• The public should be encouraged to report examples of potential biosimilar misinformation to health authorities.
• Reviewers and editors of scientific journals should be aware and rigorous to ensure publications about biosimilars are truthful and balanced.
• Biosimilar education should be stimulated and incorporated in the curricula of all medical, nursing, and pharmacy schools.
• Patients should receive information about biosimilars in graphical format in an understandable way.
• Messages about switching should be framed positively to the patients by all HCPs.