The benefits of biosimilars have long been championed in the medical sector, but with their use set to increase in emerging economies, securing the ever-expanding cold chain becomes more important. Gerhard Hörl, managing director of Medizone, looks at how to mitigate the associated risks.

Biologicals already dominate the bestselling medicines in Europe, accounting for eight of the top ten drugs now sold. As more emerging countries start to recognise their benefits, within the next few years, over 50% of newly approved medicines will be biopharmaceuticals.

Gerhard Hörl has been at the forefront of biosimilar development since joining the medical industry in 1985. Working for biopharmaceutical multinational Sandoz, he rose to become its regional head in Europe before leaving in 2005 to set up Medizone. Initially focusing on unlicensed medicines, attention shifted to the supply of analytical samples and comparator products for clinical trials to companies developing biosimilars.

"In the beginning, it was very nice because we didn’t have too much competition and we were dealing on an almost exclusive basis," says Hörl. "Eventually, many more realised the potential of biosimilars and the market took off, and with that it has become a lot more competitive. What we do in the company is supply reference products for analytical development as well as for clinical trials. We deliver to anywhere in the world in the way that customers really want, in terms of the packs, the batches, the expiry dates and documentation."

The fragility of biosimilars means that they are very sensitive to enzymatic action in the manufacturing process, while their physical instability makes storage and handling particularly precarious. Chemical and physical volatility may contribute to a loss of activity and with temperature control one of the major factors in maintaining their quality and integrity, transporting them can be a risky task.

"If a product is very difficult to source in bigger quantities we jointly develop a long-term sourcing plan with our customer, buying well in advance," says Hörl. "We work quite far ahead of time in order to complete the projects, calculating the risks that might come through interruption of the supply chain. We ensure that the companies involved in biosimilars development get whatever they need at the price they need."

"We have a very good understanding of what is going on in the market and we try to explain to our customers all the potential pitfalls surrounding biosimilars. The problem is not just that the supply is limited; the originator companies don’t support clinical trials and therefore have to source products through our network of partners. We explain what we feel is possible, what is realistic and then, once they’ve got all the facts and figures together, we can develop a sourcing plan."

Sensitive cargo
While the majority of Medizone’s customers remain in Europe, the US and Canada, it has seen a tremendous surge of activity in Eastern Europe, Latin America and South-East Asia. Such growth has not been without its complications though; the susceptibilities of biosimilars to temperature shifts means careful planning is required to operate in regions with more extreme climates.

"We’ve seen products popping up in countries like Vietnam, and even Iran, countries I’d never imagined would have the financial muscle to get into biosimilars," says Hörl. "Shipping those products to places like India is a special challenge. The climate is so different to what we have in Germany, so we have to be extremely careful to avoid breaking the cool chain. Even minimal mistakes in documentation can hold up shipments at customs for several days and this can be lethal for a product if it results in an increase in temperature.

"Sometimes there is a disruption on the originator side. We recently had a big story about products from Italy that left the legal supply chain, they were imported into Germany and now these products have to be withdrawn from the market."

As the market for biosimilars shows no signs of slowing down any time soon, and with globalisation increasing, the risks are only likely to increase. Avoiding similar scenarios will require the rigorous safeguarding of the cold chain, and the need to partner with reliable, experienced suppliers becomes greater.