Accelerating European market entry for Asia-manufactured biosimilars

An Asian biosimilar company needed a flexible European localization partner capable of converting large bulk batches into many small, country-specific SKUs at speed.

We delivered a cold chain–enabled solution designed for agility, complexity and accelerated market entry.

The challenge

Our global pharmaceutical customer produces high-volume batches of biosimilar drugs for delivery in vial, pre-filled syringe and autoinjector device formats. Their challenge was converting these into the much smaller and highly variable batch sizes required across Europe. Large markets often needed 10,000 to 20,000 units, while smaller countries required only 100 to 300 units in total.

Managing this complexity at the point of manufacture in Asia would create delays and risk. Market needs frequently changed by the time the product reached Europe. Since speed to market is critical in biosimilars, the company needed a European partner able to perform late-stage customization with maximum flexibility.

The solution

We devized and implemented a two-path model that included fully automated lines for large batches and semi-automated lines for smaller runs. A major component of the solution was expanded cold chain storage at our facility in Poland, which allowed the customer to ship bulk product early and determine market allocations later.

With capacity increased to 1,800 cold chain pallet spaces, we created a highly adaptable operation that could adjust daily or weekly to changing demand. This dual-format approach ensures efficient processing across vials, pre-filled syringes and autoinjectors while supporting fast and reliable European market entry.

The execution

Each new SKU began with an engineering assessment to confirm the tooling requirements, followed by the purchase of new format parts when needed. Process validation took place in parallel with workflow development. Once complete, we conducted PPQ runs to verify the process stability before providing all the validation documentation the customer needed for their regulatory submissions.

During this period, the team coordinated artwork process, packaging procurement, and safety stock planning. They also managed an intricate supply chain that receives drug product from several European and Asian manufacturing locations.

Our ability to adjust production schedules quickly to balance product deliveries and changing demand within each target country, without compromising quality and regulatory requirements, sets us apart from larger competitors that cannot accommodate frequent changes.

The impact

Fast and more reliable launches across more than 25 markets in Europe and beyond.
Reduced delays and protected critical timelines due to our flexible planning and rapid batch switching.
Supported the customer’s strategy to be first to market with their biosimilar products.
Provided certainty and operational clarity by managing the final and most time-sensitive stage of the supply chain.
Localized batches reached the right markets when needed through reliable delivery, real-time adaptability and efficient handling of country specific requirements.

Do you need flexible support with complex market customization in Europe or the Americas for your next biologic or biosimilar drug product?

Get in touch today. We’re ready to help.

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