New FDA Guidance on “Considerations in Demonstrating Interchangeability with a Reference Product” – How West is Working to Support Biosimilar Companies

The development of new biosimilar products has increased over the past several years. Europe and Asia Pacific have been leading the industry with the greatest number of biosimilars being introduced to the market. Given the demand to reduce medical costs for patients, this trend is expected to increase globally in the coming years.

In May of 2019, the US FDA issued industry guidance, Considerations in Demonstrating Interchangeability with a Reference Product, to companies wishing to develop biosimilars in the US market. This new guidance provides direction to biosimilar manufacturers on the FDA expectations for demonstrating interchangeability of a proposed therapeutic protein product with the reference biologic product. While the guideline is specific for therapeutic protein products, it can be applied generally to all biosimilar development programs to aid manufacturers to better define their development pathway for approval. To achieve this, a manufacturer must have shown the biosimilar is highly similar with no clinical meaningful difference to the reference product. Once a marketing application is approved, the proposed biosimilar may be substituted by a pharmacy at the point of dispensing the medication to the patient or caregiver.

Similar to biologic development programs, developing a biosimilar can be challenging and expensive. With biosimilars though, there is added complexity in terms of needing the process, product and packaging ‘know-how’ that closely mimics the innovator’s process, product and packaging. On top of the routine testing, biosimilar companies have the potential to maximize their product’s uptake by conducting a switching study, as defined in this recent guidance. Biosimilar developers need to demonstrate similar efficacy as the innovator’s reference product, while also understanding the appropriate regulatory framework and necessary test regime for the biosimilar. The need to understand the interchangeability guidelines and the way to design a switching study are pivotal to minimizing delays and overspend whilst maximising speed to market.

There are multiple biosimilar molecules in development for many of the marketed biologic molecules, however the first biosimilar entering the market is usually rewarded with the largest share of biosimilar prescriptions. The potential growth in the biosimilar market is substantial and getting more competitive. Companies can choose how they wish to approach this market, i.e., to directly copy the innovator, who may also be looking to change its offering to extend the drug lifetime and minimize biosimilar impact, or to offer the drug in a combination product to offer patients and prescribers a differentiated choice.

At West, our team understands the unique challenges of biosimilar development and can assist customers with a variety of solutions, designed to help move products to market faster and more efficiently, to improve patient health. These services and solutions include:

• In-depth knowledge of primary packaging to offer protection and stability for the biosimilar over its shelf-life
• Expertise in combination products in the area of administration and delivery systems
• Small quantity, ready-to-use primary packaging components, pre-validated as a system
• Integrated solutions to conduct product characterization of innovator packaging to support technical evaluation and clinical trials
• Regulatory guidance on test regime, component selection, process and manufacturing approach
• Compatibility testing (e.g. E&L, CCI, supporting switching study requirements)
• YBB compliance for the China market
• Analytical service roadmaps for testing designed to mitigate risk and accelerate time to market
• Extractable data packages already available
• World-class cGMP & FDA compliant laboratories to meet stringent regulatory requirements
• In-house small-scale hand-filling of devices for technical and compatibility testing
• Access to sterile Fill & Finish for small to mid-size manufacturing runs
• Device manufacturing, assembly and drug handling capability

If you would like to learn more about how West is working by our customers’ side to support biosimilar development, or if you are a reference company wanting to maximize your product lifecycle, please contact us or visit our Integrated Solutions Program page on our website.

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