Asia Pacific has become a global powerhouse for biopharmaceutical industry growth, especially when it comes to biosimilars. The region is home to a vast and growing population, deep pools of patients interested in clinical trials, and an increasingly sophisticated regulatory environment. The global biosimilars market is expected to reach a massive US$35 billion by 2020 — up from only US$1.3 billion in 2013. These lower cost treatment options offers tremendous potential to bring affordable treatments to populations in Asia who are desperate for cost-effective medicines — but only if developers in the region can figure out how to develop and deliver biosimilars to market before their competitors beat them to it.
Unlike generics of traditional medicines, which are also popular for developers in the region, getting a biosimilar into the marketplace can be a lot more complicated due to the inherent complexity of working with living cell banks. To succeed in this space, developers will need strong manufacturing capabilities, and they will likely need to partner with other clinical trial experts to avoid the pitfalls that might otherwise derail their progress. Developers who follow these steps can avoid the most common pitfalls and ensure their project plan is best positioned to efficiently deliver these products to market.
- Understand the reference product. Unlike generics, which are identical reproductions of a small molecule reference product, biosimilars are highly similar copies produced in living cells. That means even small changes in the process can result in a product that does not deliver the same safety and efficacy as the original. To ensure your biosimilar meets safety and efficacy requirements, you need to thoroughly research the originator drug to make sure your team understands exactly how it was designed, and what pitfalls the original developers faced. That process should include analyzing multiple batches of reference product to understand variability issues; and reviewing the pharmacokinetics (PK), pharmacodynamics (PD), mechanism of action (MoA), safety and efficacy profile of the reference product.
- Develop the device in parallel. All biologics are given parenterally, however, specialized delivery devices, such as an autoinjector, are frequently used for administration. Pursuing these projects simultaneously will shorten the time to market, and ensure you address regulatory requirements for this critical piece of the approval process.
- Get regulatory advice early on. Biosimilars are a new and rapidly evolving field, and not all regulatory agencies have settled on an approval process. While many countries have introduced an abbreviated pathway for biosimilar approval and have issued supporting guidelines, there are variations among them that must be accounted for during the project planning process. Research your regulatory requirements careful, to be certain you understand exactly what data authorities require to give their approval. This will allow you to optimize your development program and help you avoid surprises during the marketing application assessment process.
- Do not try to replicate the innovator’s clinical development program. Biosimilars are copies of already approved biologics. The safety and efficacy profile of the innovator product is already established, which means there is no need – or regulatory expectation – to replicate the clinical development program followed by the innovator. In addition, the development program implemented by the originator may now be antiquated, thus requiring newer biochemical assays and modifications due to new Chemistry, Manufacturing, and Controls (CMC) requirements by both the U.S. Food and Drug Administration and the European Medicines Agency.
- Address obstacles to commercialization up front. Marketing biosimilars is a complex proposition that requires both special manufacturing and marketing needs. Because many biosimilars manufacturers in the region do not have these capabilities in-house, they prefer to enter the market with one or more partners who can fill in the knowledge gaps and help them achieve efficiencies while de-risking their market strategy. Whether you are going it alone or working with partners, you need a sound commercialization and marketing plan focused on communicating with prescribers about the safety and efficacy of the biosimilar in order to influence uptake.
- Consider the competition. Biosimilars are a popular development path, which means there may be other competitors working on related projects, which can lower your potential return on investment. To be profitable, biopharma companies must choose their target products carefully, taking into account how their biosimilar will compete with newer novel technologies, and looking for opportunities to accelerate delivery, like launching Phase III programs based on interim Phase I safety data. Companies should also be certain that critical patent expirations for innovator drugs are likely, and that their project plan has a high probability of hitting its time and cost targets to ensure marketability and ROI projections.
By following these steps, and aligning with strong partners who understand the complexity of bringing the right biosimilar to the right market, developers can gain a significant competitive advantage in this burgeoning field.
To read more about strategic models for growth in Asia-Pacific, please read "Affordable therapies: Gaining a competitive advantage in Asia-Pacific"