The Rise of Biosimilars and their Impact on Cold Chain Logistics

The pharmaceutical sector has seen exponential growth in biosimilars and there are no signs of this pace slowing down. Mckinsey estimates sales of biosimilars will triple to $15bn by the year 2020. In the UK, this recent market surge has been influenced by October’s patent expiry of adalimumab and the National Health Service (NHS) issuing new commissioner guidelines encouraging a switch to biosimilars if it is cheaper than an original product.

Biosimilars are essentially a copy-cat product of a biological reference product. However, unlike generics, they are not identical to the original product and only have similar properties. Companies must ensure though that the product is equivalent in terms of quality, safety and efficacy. As the NHS is under serious pressure to drive down costs, it is unsurprising that they have opened up their doors to biosimilars. Effectively, they receive the same quality of product at a significantly lower cost.  

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What are some challenges in the Cold Chain?

Even though biosimilars are providing substantial benefits to the healthcare sector, they are demonstrating significant challenges in cold-chain logistics.

• Temperature & Time

  Biosimilars are considerably temperature and time sensitive and they require consistent monitoring throughout the supply chain to maintain a product’s integrity. Biosimilars have a very short label claim, so every delivery needs to be extremely time efficient. Alongside this, their extreme temperature sensitivity requires them to be stored within a specific temperature threshold throughout the entire journey.

  To overcome these challenges companies have begun utilising cutting-edge technology such as IoT. IoT sensors allow companies to track a product’s condition (temperature and humidity) and real-time location. Alongside sending instant alerts when any deviations occur. Logistic companies have also been investing in pioneering cold chain packaging, which is integral to maintaining product integrity, not only to sustain the temperature threshold but also to handle any vibrations or drops.

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• SMEs

  Biosimilar production is not just being monopolised by the larger players in the market, SMEs are also producing mass amounts of biosimilars. Whilst this is brilliant in terms of competition and pricing of the products, smaller companies usually have less established supply chain operations and tend to outsource to external agencies. As a consequence, the choice of supplier is vital as not all logistic companies maintain the required standard needed by biosimilars. In addition, manufactures lose visibility along the supply chain, increasing the chance of a cold chain breach.

• Globalization

  As biosimilars are more affordable than their original counterpart, they are more accessible to a greater variety of people and can even be available in developing countries. The global transportation of biosimilars opens up more possibilities of a broken cold chain as it becomes increasingly more difficult to monitor. The majority of breaches occur on airport tarmac, where the products are left to stand, exposing them to external conditions. The globalisation of these medicines also means they will be travelling through various terrains, subjecting them to different climates. Therefore, the packaging needs to be highly effective to maintain temperature thresholds, even under the harshest of conditions.

  The growth of biosimilars does present a lot of challenges for the logistics sector, however, it is wise for companies to embrace it and see it as an opportunity to be more innovative with their operations and develop a more efficient and effective cold chain.