Biosimilar Development – Big Boys Game

As part of my role in my company I’m constantly reading about the many companies who are entering the biosimilar race. An interesting question raised by one of our staff members is why aren’t these multitude of small companies breaking through in the US and EU markets ? Some companies in India and China are seeing significant success in their local markets selling the “biosimilar” version of some these expensive biologics. Why aren’t they entering the US and EU market to drive biosimilar pricing even further down ?

Looking into this question a little closer, we have reviewed the recent approvals of biosimilar in the USA and EU. Let’s look at some of the companies that have at least 2 biosimilar approved either in the US or EU at of February 8-2018.

  1. Amgen
  2. Sandoz
  3. Boehringer Ingelheim
  4. Biogen
  5. Samsung Bioepis
  6. Teva
  7. Hospira

Is there anything telling about the list ?

Why are these companies successful ?

Do you notice any small to medium size company on the list ?

Where are the high flyer biosimilar start-ups from 2010 ?

The simplistic answer is that producing biologics is high science and is some case more difficult that creating the originator. Obtaining approval takes time, development effort needs to be methodical and clinical programs need to be run almost flawless. This off-course assumes that the biosimilar candidate is analytically and statistically similar to innovator target.

The list of companies who have achieved approval so far have tended to be well established companies with deep pockets and long term experience dealing with the regulatory agencies. These companies have extensive experience resources in the key scientific areas required to commercialize biosimilars. Companies like Sandoz and Amgen have been working with biologics for greater than 15 years and have developed internal experts that have guided their programs.

While 2017 was a good year for Biosimilars and 2018 looks even more promising, the cautionary tale in this simplified post is that it very difficult to bring Biosimilars to market. The companies who have been successful have scientific understanding, regulatory expertise, manufacturing know-how and enough money to ensure all the approval boxes are checked.

The number of biosimilar being added to companies pipeline is growing significantly as there is another big wave of patent expiration between 2021-2025. As an executive of these companies I would look very closely at how the companies in the list above obtained their approval and look into their playbook to develop or course correct their strategy.

Obtaining approval in Europe and US requires significant amount of money, expertise, luck, understanding of regulatory requirements and great science. The product approval history so far does not favor anyone that does not have these pre-requisites.

As always I welcone your comments and suggestions. You can reach me at robert.salcedo@biosciencescorp.com