Methodologies in Biosimilar Product Development

The FDA has withdrawn draft guidance on analytical similarity assessment and evaluated various methods for assessing analytical similarity based on current guidelines. It provides a general approach for using the n-of-1 trial design for interchangeability assessment and discusses the feasibility and validity of non-medical switch studies. It also offers innovative thinking for detecting possible reference product changes over time.

Format: Paperback / softback
Length: 380 pages
Publication date: 25 September 2023
Publisher: Taylor & Francis Ltd

The Food and Drug Administration (FDA) has recently withdrawn a draft guidance document on the assessment of analytical similarity between pharmaceutical products. This decision was made in response to feedback from stakeholders who expressed concerns about the clarity and applicability of the proposed guidance.

In its place, the FDA has developed a comprehensive evaluation of various methods for analytical similarity assessment. These methods are based on the agency's current guidelines and aim to provide a framework for assessing the interchangeability of pharmaceutical products.

One of the key approaches discussed in the evaluation is the use of n-of-1 trial design. This design involves testing a single patient with two different versions of a pharmaceutical product and comparing the clinical outcomes between the two. By analyzing the data from this trial, it is possible to determine whether the two products are interchangeable.

The evaluation also examines the feasibility and validity of non-medical switch studies. These studies involve switching a patient from one pharmaceutical product to another without any medical justification. The goal of these studies is to assess whether the patient experiences any adverse effects or changes in clinical outcomes as a result of the switch.

While non-medical switch studies have been used in the past, there are concerns about their feasibility and validity. Some argue that these studies may be subject to bias and that the results may not be generalizable to a larger population. Additionally, there are concerns about the potential for patients to experience adverse effects or changes in clinical outcomes as a result of the switch, even if there is no medical justification for it.

To address these concerns, the evaluation provides innovative thinking for the detection of possible reference product change over time. One approach suggested is the use of real-time surveillance and monitoring of pharmaceutical products. By using advanced technologies such as high-throughput screening and data analytics, it is possible to detect any changes in the composition or manufacturing process of a pharmaceutical product. This can help to identify potential reference product changes before they become a problem for patients.

In conclusion, the FDA's withdrawal of the draft guidance document on analytical similarity assessment and the development of a comprehensive evaluation of various methods for assessing the interchangeability of pharmaceutical products are important steps towards ensuring the safety and effectiveness of pharmaceutical products. The use of n-of-1 trial design, non-medical switch studies, and innovative thinking for the detection of possible reference product change over time are all important approaches to addressing the concerns raised by stakeholders. However, it is important to ensure that these approaches are implemented in a rigorous and transparent manner to ensure the safety and well-being of patients.

Weight: 453g
Dimension: 234 x 156 (mm)
ISBN-13: 9781032071800