With more biological blockbuster drugs now off patent – or with an impending patent cliff – interest has grown in developing biosimilar medications. There are currently ~700 biosimilar trials being conducted globally and many of these are unique molecules. Biosimilars are highly similar to an approved biological drug, known as the reference product, and have been shown to have no clinically meaningful differences from the reference product. This webinar will use biosimilar case studies to address the operational challenges of reference drug sourcing, supply chain design and study execution to assist development efforts.
Smart Reference Drug Sourcing
Sponsors confront an array of obstacles that are unique to biosimilars, including sourcing and managing reference drug medications. Given the role of reference products in obtaining regulatory approval for biosimilars, the ability to source those products for comparative clinical trials is a top priority. Therefore, access to a global network is needed in order to source a sufficient supply of reference products from innovators and authorized local distributors.
Purchasing small batches of product, accompanied by necessary documentation, from a variety of sources in multiple regions, is preferred for building up the reference library. During this characterization phase, multiple batches offer a distinct advantage in biosimilar development. The use of multiple batches with differing expiry dates demonstrates to regulatory bodies that compounds are of the same purity and maintain the same safety and efficacy profiles.
The development of a biosimilar most often implies sourcing of high price reference drugs. Clearly, this is an area where strategic planning and sourcing efficiency can reduce costs and increase success in biosimilar trials.
Advanced Blinding Techniques
Unlike most clinical trials for innovator products, biosimilars typically call for blinding in Phase I pharmacokinetic and pharmacodynamic studies. That means there is greater risk of releasing sensitive, blinded, information earlier in development when clinical trial staff often have a broader array of responsibilities. To address this risk, it makes sense for sponsors to consider blinding options and supply chain design early in the study planning process.
While there is no consensus, some regulators addressing biosimilar trials have expressed preferences for designs that require blinding. The European Medicines Agency, for example, is prescribing two clinical trials of randomized, double-blind crossover or parallel design. Notably, many current development programs are using unblinded pharmacists at clinical sites, which potentially could lead to additional questions from regulatory agencies at submission. From a packaging perspective, available blinding solutions on the market include opaque shells for vials or syringes. Though important, selecting components may not be the hardest part of protecting the blind. Perhaps more challenging are aspects such as ensuring proper configuration of the interactive response technology, establishing a blinding procedures checklist, and staying vigilant during communications.
The opportunity for improving health care at lower costs makes biosimilars an attractive investment for many companies. However, the great promise of biosimilars presents unique operational challenges that make these clinical studies exceptional.
Key Learning Objectives
During this webinar, subject matter experts will discuss these opportunities and challenges and provide tips on how to achieve success in running biosimilar clinical trials, including:
- Understanding global reference drug sourcing challenges and solutions for the development phases characterization to phase III
- Developing reference drug sourcing strategies for biosimilar trials to ensure supply throughout the trial
- Designing a resilient clinical supply chain strategy that anticipates the unique challenges of a biosimilar trial
- Using practical case study examples to help avoid common mistakes
Keywords: Drug Sourcing, Clinical Trials