There is a ballooning interest in biosimilars and interchangeable products in the pharmaceutical industry, especially with the first biosimilar in the United States being approved in 2015. The Food and Drug Administration continues to review other marketing applications for proposed biosimilar products.
The FDA has announced that they have developed a free, Continuing Education Course for healthcare professionals, FDA Overview of Biosimilar Products. This course was created for healthcare professionals to strengthen their knowledge and understanding of biosimilars and interchangeable products. For example, biosimilars and interchangeable products are not generic products, and the course will help healthcare professionals fully appreciate and understand the distinction.
The course will help healthcare professionals understand how a biosimilar can be prescribed and dispensed, and how and when an interchangeable product can be substituted for another biological product. The course will also explain the development process and approval pathway for biosimilars and interchangeable products, and includes information about the FDA’s general review process for these products.
The course is available to healthcare professionals on FDA’s CDERLearn Website, and can also be completed on a tablet. At the end of the course, you will have the option to obtain CE credit by registering with your credentials. Once you have successfully completed the online assessment activity, your appropriate CE accrediting body will issue a certificate.
Healthcare professionals who complete the course will be able to: identify the changes to the law granting FDA authority to approve and regulate biosimilars products; understand biological products and biosimilar products; recognize the key terminology related to biosimilar products; and describe the FDA’s general approach to the development and approval of biosimilar products.
Module Two of the course goes through the Biologics Price Competition and Innovation (BPCI) Act of 2009. It explains the way reference products and biosimilar products are evaluated by the FDA, and how the evaluation and approval process allows biosimilar products to be available at a potentially reduced cost, in comparison to the reference product. Module Two also includes a definition slide, which explains the difference between a generic drug, a biological product, a reference product, a biosimilar product, and an interchangeable product. Module Two closes out with a “Knowledge Check” of term definitions.
Module Three explains what a biological product is and the way they may be derived from natural sources such as human tissues, manufactured through biotechnology, or produced synthetically by other cutting-edge technologies. Module Three further explains that most biological products are complex molecules that are not characterized as easily as most small molecule drugs. The importance of tightly controlled manufacturing conditions for biologics is also explained in this module.
Module Four explains the complexity of biological product manufacturing. One such complexity is that many biological products are derived from natural sources, and therefore still show some variability. Therefore, the pure nature of biological products means that there can be variation within one single batch of product. Module Four continues, explaining lot-to-lot variability and how to assess and control it to ensure consistent product quality.
Module Five goes through what a biosimilar product is, and has a slide dedicated to the difference between a biosimilar product and a reference product. Module Five also explains that while biosimilar products may have some differences from the reference product, they must meet certain standards and the biosimilar sponsor must sometimes provide sufficient data and information demonstrating that the products are highly similar and that the differences are not clinically meaningful. This module also closes out with a Knowledge Check.
Module Six presents the abbreviated approval pathway for biosimilar products. It explains the general requirements for the abbreviated approval pathway and the importance of analytical studies.
Module Seven describes the standards for approval. The slides explain the “stepwise approach” that the FDA recommends sponsors use to develop the data and information needed to support a demonstration of biosimilarity. The FDA recommends that at each step, the sponsor evaluate the level of residual uncertainty about the biosimilarity of the proposed biosimilar product to the reference product and identify the steps they should take to address that uncertainty. The slides continue on with a step-by-step analysis of the five steps: analytical studies, animal studies, clinical PK/PD studies, clinical immunogenicity assessment, and additional clinical studies.
Module Eight is the conclusion, which provides contact information for relevant agency contacts and provides an opportunity for attendees to obtain either CE credit or a certificate of completion (for those not trying to obtain CE credit).