Helping you develop the medicines people need is something we take personally. We are passionate about improving patients’ access to medicines, and this is reflected in our commitment to biosimilars development.  We aim to partner with you to add value to your biosimilar program beyond the pure execution of your studies.

We take a holistic view of biosimilar drug development, leveraging a cross-functional team of biosimilars experts, including therapeutic physician specialists, biosimilar operational experts, regulatory consultants, biosimilar CMC experts, pre-clinical scientists, and commercial consultants who can partner with you to develop the optimal clinical development and commercial strategy to maximize the value of your asset.

Capabilities include:

  • Indication choice and sequencing to accelerate regulatory approval, maximize cost efficiency, and optimize return on investment
  • Clinical Development Plan development – lean protocols with minimized physician and patient burden that satisfy regulatory requirements and enable switching strategies post approval.
  • Finding the right markets for your product development 

Finding the right markets for your product development

Because the originator product is often the comparator drug in these trials, and markets may vary in the acceptability of this construct, site and country selection can be challenging.  We can help you identify the optimal markets for both clinical trials and commercialization. At the site level, there can be a lack of experience with these sorts of trials. We can help find and train investigators who will best support your program.

Handling your clinical trial applications

INC Research has extensive experience with biosimilar regulatory submissions across a variety of indications. We combine this experience with our close relationships with regulatory authorities to ensure we supply them with the data necessary to accelerate your route to market.

Our drug development experience with biologics

We’ve helped to develop both original biologics and biosimilars across a range of indications, including epoetin, infliximab, insulin, monoclonal antibodies, rheumatoid arthritis, cancer and endocrine disorders. Our support has ranged from generating and executing clinical development plans to supporting customers in advisory meetings with the authorities in Europe and the United States.

Our depth of expertise and strength of experience globally across the many functions necessary for successful biosimilar development, regulatory approval, and commercialization make INC Research your CRO of choice.