FOCUS ON BIOSIMILARS
Our founders were among the first pioneers in the biosimilars field since 1996, and initially Biosimilar business was one of our main focuses. We have significantly contributed to the development of the first two biosimilars, rhGHs leading to approvals on the European scene in 2006, and later to the development of the first modern long acting rhGH approval in Europe. We have expertise from simple polypeptides to complex monoclonal antibodies. Since then, we have continued to serve Sponsors working with biosimilars while expanding our capabilities in the areas of other important therapeutic fields.
Accelsiors is among the very first CRO companies that has supported biosimilar development for the US market (Filgrastim, pegfilgrastim, trastuzumab, epoetin).
- Accelsiors took part in 10 biosimilars and several “biobetters” development programs
- We have conducted over 30 biosimilar studies from Phase I to Phase III registration studies
- We have recruited over 6000 patients and have engaged in over 600 study sites in different therapeutic indications
- We have contributed for successful out-licensing of the biosimilar products for 4 companies
- We contributed to several Marketing authorizations in Europe, and some in other regions, having other products in submission process both in Europe and North America
Our main goal is to assist you in the selection of the best possible solution for the development of your biosimilar or improved biologic (biobetter).
The extensive experience of Accelsiors in the development and registration of both biosimilars and biobetters places us among the few companies that truly understand the regulations, opportunities and challenges in this field.
Development of biosimilars requires a holistic approach irrespective of whether it is a simple follow-on polypeptide, a complex mAb, or a vaccine, maybe even a blood factor, or a “biobetter”. In order to be successful, one must be able to translate the CMC particularities into clinical language, or the other way around. Successful biosimilar developers have to have both an expert level of knowledge in diverse specific clinical and non-clinical fields, and a very broad general knowledge in pharmaceutical industry. Accelsiors possesses these capabilities of pharmaceutical polyhistors.
Combining our proficiency in different therapeutic areas, with well-tailored service capabilities and access to diverse patient populations, Accelsiors will support every aspect of clinical and nonclinical development of your biosimilar or biobetter compound – from pre-clinical development through successful conduct of Phase III registration trial.
Accelsiors possesses a very significant experience in development of various “Biobetters”, molecules that are modified by protein or glyco-engineering, which are more efficient, require lower dosing frequency and, most critically, reduce the risk of immunogenicity. We would be honored to share this knowledge and experience with you to boost your biosimilar or biobetter development program.
We are offering the following services:
- We will help you find out the most optimal study design, specifically tailored for your biosimilar drug candidate;
- We will help you select the optimal equivalence margin to achieve a reasonable sample size;
- We will help you in identifying the most sensitive endpoints able to detect meaningful differences among compounds;
- We will help you implement the most sensitive assays in your studies to be able to meaningfully detect any differences between studied drugs;
- We will cost effectively monitor and manage your biosimilar studies;
- We will help you in understanding what is the legal basis for bio-comparable medicines;
- We will help you figure out which actual routes are open to filing with limited data;
- We will help you in designing the strategies for immunogenicity evaluation in comparability studies
- We will advise you on the most suitable types of neutralizing antibody essays and their characteristics considering the most current regulatory expectations;
- We will help you in optimizing your IP strategies for biosimilar life cycle management when taking patent law and regulatory protection into account;
- We will help you turn safety challenges of your actual biosimilar into opportunities to create a win-win dimension and strengthen your business;
- We will help you in outlining the process for development of monoclonal antibody (mAb) biosimilars;
- We will point out the specific technical issues concerning mAbs, and will clarify issues of clinical proof of similarity;
- We will help you understand the “switchability” and “interchangeability” concept and will support you to timely recognize the associated challenges in finding out the best pathways in their development;
- We will advise you on how to explore technologies for producing biobetters in the best way, including drug delivery, half-life extension, cell production, and glycoengineering methods
- We will assist you in identifying the most promising peptide, protein, monoclonal antibody and glycan targets for biosimilar development.