Biosimilar development

Biosimilars experience: Spanning from the early beginnings

Many of our professionals were involved in biosimilar drug development beginning from the advent of this innovative field, since 1996, guiding and managing the first biosimilar drug development projects in the world and are supporting clinical trials, as well as registrations in this area.

We understand the challenges, opportunities and success factors of biosimilar drug development. We have the in-depth experience, expertise and the right capabilities to perfectly handle the complexity of your biosimilar study.

  • Our regulatory experts can support you to reduce time and cost of navigating throughout the maze of the global regulatory landscape
  • Our established site relationships with investigators experienced in biosimilars allow for accelerated start-up and patient access
  • Biosimilar Knowledge Network: benefit from our first-class relationships with key opinion leaders in the biosimilar area
Do you need more professional help?

Feel free to ask Accelsiors’ Biosimilar Drug Research experts! Please contact us:

and we will schedule a meeting around your calendar!

Accelsiors’ experts have built numerous biosimilar trial designs and managed clinical studies in various therapeutic indications. We have conducted:

  • over 30 biosimilar studies from first-in-human Phase I clinical trials to complex Phase III registration studies
  • 10 biosimilars and several “biobetter” development programs from simple peptides to complex monoclonal antibodies, including the first modern long acting rhGH
  • We have taken part in several successful out-licensing and marketing authorizations of biosimilar products both in Europe, North America and in other regions around the world

Access to the key opinion leaders in Biosimilars

Let us provide open access for you to the best brains in medical, regulatory, biostatistics and data science to boost your biosimilar or biobetter development program.

Take advantage from our unique initiatives:

  • Biosimilar Knowledge Network: Our professional network with invited academic scientists, regulatory professionals and world-prominent biosimilar development experts is based on our first-class relationships with key opinion leaders in the biosimilar area, providing an unique, best-in-class scientific support for our clients’ special needs.
  • Annual Biosimilars Forum professional event series:
    In cooperation with our prestigious international scientific institute partners (the Viennese Section of the IBS and the Hungarian Society for Clinical Biostatistics), Accelsiors launched the Annual Biosimilars Forum event series in order to provide even more effective support in sharing of recent scientific and practical knowledge for professionals who are working in and for biosimilar drug development. We provide a opportunity for a constructive and open dialogue between regulatory professionals, clinical researchers, medical scientists, statisticians and pharmaceutical developers.

Discover our Biosimilars Forum event series!

Quick patient access – Acceleroute™

The biggest cost generator in a study is length of the recruitment and maintenance of inefficient sites. Through our proprietary platform called ACCELEROUTE™, we ensure the most efficient recruitment based on our best-in-class site relationships, historical data and up-to-date feasibility data. With this unique and very pragmatic approach are able to extract the most optimal site portfolio that will deliver the patients you need in a timely and cost-effective manner.

Personalized support from a dedicated Biosimilar development team

We provide you flexible support and tailor made solution because we know that each biosimilar development program is unique. Our team will engineer your development program with success in mind, supporting you with open, consultative approach, driving the study from design to execution and deliver your product to market in the most time and cost efficient way. Accelsiors’ Biosimilar team consists of experienced scientific, medical, technical, clinical, logistics and regulatory professionals. Our specialized staff is experienced in all phases of clinical development with key knowledge of all the regulatory pathways in biosimilar clinical trials.

Learn More About Accelsiors’ Flexible Capabilities

High standards in project methodology
Preventive, risked based Quality Assurance
Global CRO capabilities
Comprehensive Clinical Development Services
Use of state-of-the-art integrated technology

Are you interested in more information about Accelsiors CRO? Let us know how we can best support you in clinical drug development.

Connect with Accelsiors!