What are Biosimilars?

Biosimilars have revolutionised the treatment and prevention of many disabling and life-threatening diseases. A biosimilar (similar biological medicinal product) is a biological medicine that is similar to another already authorised for use, with comparable quality, safety and efficacy, which is known as the “approved reference medicinal product”.

Due to their high degree of similarity with the biological reference product, they have no meaningful differences from the reference product in terms of quality, safety or efficacy. The purpose of a clinical trial for a biosimilar is to confirm similarity with the originator biologic product and not to establish safety and efficacy all over again.

These drugs are mostly derived from biological sources such as animal cells, bacterium and yeast. Biosimilar drugs can either be small molecules such as human insulin, erythropoietin, human growth hormone G-CSF or complex large molecules such as monoclonal antibodies.

Sourcing Biosimilars

At BAP Pharma, we understand that sourcing innovator products for biosimilar development can represent many challenges. Shortages, manufacturers restrictions, documentary difficulties and government regulations can make sourcing difficult.

We have extensive experience in sourcing products for biosimilar studies. BAP have pioneered innovative solutions by purchasing directly from innovator companies, ensuring pedigree of products and continuity of supply, with different batches and expiry dates. In addition, we have sourced specifically for analytical purposes, before and after the launch of an innovator product.

We have established an excellent track record in the development of biosimilars, delivering even the most difficult to source products. We are proud to have supported development of the following biosimilars:

  • Remicade
  • Enbrel
  • Humira
  • Herceptin
  • Mabthera
  • Avastin

More about Biosimilars

Growth in biologic drugs is set to grow by 9% per annum, and is estimated to grow to $314 billion by 2020. Europe is the most important market for biosimilars and represents 80% of global spending and is expected to increase from around 2.4 billion EUR in 2016 to 23 billion EUR in 2020. The biosimilars and follow on biologics market is expected to drive growth through to 2026, as many leading biologic drugs lose exclusivity over the next seven years.

There are constraints in developing and registering biosimilar drugs owing to the variability in raw materials and complexity in the manufacturing process. Developing biosimilars is expensive in terms of both time (5-7 years) and money (180-275 million EUR). As biosimilars are only “similar” to a biological medicine, they have to undergo complex regulatory compliance. There are different approaches to regulation, which are still evolving, all of which have an impact on the development and approval of biosimilars.

That being said, growth opportunities are attracting major interest in biosimilars. Biosimilars are expected to generate cost savings for patient populations and hence represent a growing share of drug spending for health care systems. This means they are becoming increasingly important in the pharmaceutical industry.

Many leading pharmaceutical companies are looking to expand into a market which offers both long term growth, limited (albeit fierce) competition, and relatively low risk. We at BAP Pharma have experienced this rapidly increasing demand for biologics and the drive to develop biosimilars.