Next Generation of Biosimilars and Biobetters – Challenges and Opportunities

The future of biopharmaceuticals are “biosimilars.” Highly similar to already approved biologic drugs, biosimilars represent an estimated $240 billion market by 2030.

The biopharmaceutical market is seeing a rapidly growing class of therapeutics showing significant potential in new treatments in oncology, diabetes, and other disease areas. There are hundreds of monoclonal antibodies, vaccines and biologics currently in clinical development, however, the future of biologics is not focused solely on the discovery of new therapeutics. There is a significant market for biologic drugs that demonstrate a high similarity to an already approved drug (biosimilars). Biosimilars are important as they offer an alternative to the original drugs which may also be much more expensive. But since biologics are made with living cells and no two molecules can be exactly the same, making a copy of a biologic is a much more involved and expensive process than creating a generic drug. There will always be differences between the biosimilar and its reference biologic.

One approach to developing biosimilars is to differentiate them in ways such as improving the delivery system, making the drug more convenient for


patients, or even focusing on the molecule itself to improve tolerability (biobetters). Considering all the recent and upcoming patent expirations of biologic drugs, the demand for biosimilars is poised to increase exponentially. The more prepared drug manufacturers are for these patent expirations, the more these companies stand to gain.

MedImmune, Dassault Systèmes and R&D Magazine recently collaborated on an article discussing the industry challenges of developing biosimilars and biobetters, and the opportunities waiting for drug companies who can do it successfully. Click here to read more.

Earlier this year, Dassault Systèmes also hosted a free, educational webinar, entitled, “Next Generation of Biosimilars Challenges and Opportunities,” presented by Rakesh Dixit, Ph.D., DABT.  Click here to listen to the webinar on-demand, and learn about:

  • The challenges and opportunities in development of biosimilars and bio-betters and the next generation of biologic drugs, including immunotherapy biologics and antibody drug conjugates.
  • Opportunities and challenges for early development, CMC, translational safety, PK-PD and efficacy of this next generation of biologics such as ADCs and immunotherapy biologics.


Sharon Rodger

Sharon Rodger

Editor; Internal & Digital Communications at Dassault Systemes
Sharon Rodger is the editor of Navigate the Future and a member of the North America marketing team for Dassault Systemes, the 3DEXPERIENCE company. Sailing and ski mom to Connecticut College daughter (Go Camels!). See the ocean every day and breathe. Suggestions on great podcasts are welcome.
Sharon Rodger