The process of developing biosimilars involves rigorous studies to understand the similarity of biosimilar medicine to reference medicine. The ultimate goal of biosimilar clinical trials is to show that there are no meaningful clinical differences between the biosimilar and reference product.

Biosimilars are approved when trials show that their quality, safety and efficacy demonstrate that the product’s benefits outweigh the risks. This is known as a positive benefit-risk balance. 

For biologicals, a positive benefit-risk balance is established from evidence in clinical trials, pharmaceutical quality data and non-clinical data. For biosimilars, a positive benefit-risk balance is based on demonstrating biosimilarity. This is achieved by carrying out comparability studies with the reference product.

When clinical trials demonstrate high biosimilarity with the reference medicine, the biosimilar can then rely on the efficacy and safety experience gained in studies testing the reference medicine. 

This typically means that biosimilars do not require as many clinical trials which can be lengthy and expensive. This means patients can access biosimilar products sooner and at a reduced cost.

Biosimilars have a significant advantage over biologicals when it comes to price. Because of the significantly lower cost in development, manufacturers of biosimilars can offer their products at a discount compared to the originator.

Because of the competitive advantage of biosimilars, these products are taking a growing share of the market. For example, in the 5 years from market authorisation, Sandoz’s Infliximab biosimilar, Zarxio, has captured over 50% of the market, reducing the market share of the originator, Neupogen.

This has been slower than the uptake of generic products mostly because the discounts are significantly larger for generics. This is because the development costs are even lower for these small molecule generics compared to biosimilars.

The biosimilars trend is expected to accelerate as more regulatory agencies remove major obstacles to biosimilar development. For example, removing the need for Phase 3 efficacy trials that compare biosimilars to their reference products have limited utility in the overall demonstration of biosimilarity.

Currently, in the American market, there is $40 billion of invoice spending for molecules with a biosimilar in the market. Biosimilar manufacturers are targeting a further $67 billion representing 24 molecules including the blockbuster products Humira and Enbrel.

All of this is interesting but how can this knowledge help the sponsors of clinical trials that need biological medicines for comparators or comedications?

Increasingly, sponsors are expected to use the standard of care as the control arm of their clinical trial. This is because regulators want to see the efficacy of biosimilars compared to current practice rather than using placebos.

As biological medicines become more commonly used as first-line treatment in serious conditions, just like many oncology indications, they are required for clinical trials more often. The procurement of biological products can be a significant cost element for the trial so cost savings are very important.

Biosimilars represent a large potential saving that can have a significant impact on the trial budget. Biosimilars also have the advantage of being a more sustainable solution. As biosimilars increase in market share it can become more challenging to source the originator medicine and some pharmaceutical companies have pulled them entirely.

A trial that was initiated with the reference product will have to swap over to the biosimilar which may require a bridging study that will add extra costs. Using the biosimilar from the outset will safeguard the trial from these market fluctuations.

You can find the complete list of approved biosimilars here.

CSI has extensive experience in sourcing biologicals and biosimilars for clinical trials. We are the largest purchaser from manufacturers in Europe for 2 out of the top 5 biologics listed above.

We have supplied biosimilar monoclonal antibodies to our client studies including:

• Adalimumab         
• Infliximab
• Rituximab  
• Bevacizumab 
• Trastuzumab

To quote one of the leading manufacturers we have worked closely with: “CSI has sold more products than any other supplier in Europe”.

What sets CSI apart from other suppliers?

       1. Scientific knowledge and expertise

We understand the exact nature of biological and biosimilar products and can provide the necessary literature and knowledge to facilitate discussions and decisions.

       2. Our relationship with manufacturers

We work with a selected number of manufacturers and we can often provide solutions within 24 hours. Our manufacturers know us, trust us and are happy to work with us.

       3. We provide value-based solutions for our clients

We will often provide options both for biologicals and biosimilars to our clients after careful evaluation of the protocol. We will highlight the specifics and make our recommendation.

       4. Global transport and distribution

We can provide all of the documentation required to transport and distribute the product all over the world.

       5. Competitive product prices

We can provide competitive quotes for products and can often guarantee the price of the product for the duration of the study with the manufacturer’s agreement.

If you are conducting a study where a biosimilar might be suitable, please contact us to discuss the available options for your study.