The biosimilars boom

In this post we take a look at the world of biosimilars, where there is a growing demand for talent with more companies including those who are more well-known in other sectors joining the market.

In the UK, 6 of the top 10 medicines prescribed in hospitals are biological products. These are used to treat a range of chronic and often disabling conditions such as diabetes, autoimmune diseases and cancers. Biologics are some of the most expensive drug treatments available, costing thousands of pounds per year. So, the emergence of biosimilar products has led to more affordable products and greater patient access. In fact, the NHS has predicted that, by moving to biosimilar products, it could save £250m per year.

So, what are biosimilars?

A biosimilar is a biological medicine which is highly similar to another already approved biological medicine. Where a generic medicine contains an active ingredient which has an identical chemical structure to the reference drug molecule, a biosimilar will not be identical to the reference biologic.

Most biological medicines contain active substances which are derived from living cells or organisms. Biologics can differ in size and complexity, from simple proteins like insulin to very complex monoclonal antibodies. Due to the processes involved in deriving these biological products from cells or organisms, there is no way to make identical biologics. Therefore, as the name suggests, biosimilars have to show that they are highly similar to the original biological medicine in all aspects of quality, safety and efficacy.

Europe paving the way in biosimilar regulation

Biosimilars is one of the few areas where Europe is ahead of the US. Biosimilar medicines have been available in the EU since 2006, the first approved being Omnitrope. Since then, the EU has pioneered the regulation of biosimilar medicines leading to the approval of more than 30 biosimilars to date.

The US is almost 10 years behind the EU, having approved its first biosimilar, Zarxio, in 2015. However, the FDA is ramping up activity with biosimilars. Having only approved a total of 4 biosimilars between in 2015 and 2016, it approved 5 in 2017.

Biosimilars watch list for 2018

In late 2017, the EMA approved the Herceptin biosimilar Ontruzant for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. Herceptin has previously generated nearly $7 billion a year in sales.

Biosimilars that are expected to be available later this year include Amgevita and Cyltezo. The EMA already has 16 biosimilar products of Humira, Remicade, Lantus, Neulasta and Herceptin under review this year so the biosimilar boom is set to continue.

Best for patients & the public purse

With the NHS aiming to have at least 90% of new patients taking biosimilars within 3 months of them becoming available, a wave of biosimilars will not only save money, it will enable more patients to access much needed medicines.

Impact on recruitment

We are seeing the number of roles rapidly increase as more generic manufacturers (like Mylan and Teva), large Pharma (Pfizer's Hospira and Novartis’ Sandoz) and even companies from other sectors like Samsung Bioepis come into the biosimilars market. 

The biosimilars skill sets in the greatest demand are in chemistry, manufacturing and control (CMC), analytical and formulation development, manufacturing and production, regulatory affairs, clinical trials, business development and licensing.

As healthcare providers are pushing to reduce the costs of medicines, we can only see these recruitment needs continuing. If you are interested in opportunities in this area please get in touch with one of our expert recruiters, and we’ll be in contact to discuss potential opportunities. We’re here to help you with every part of the process: from CV advice to interview techniques. 

For more fascinating insights into the ever-changing world of the life sciences sector, stay tuned to all SRG Blogs.

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