Our main goal is to assist you in finding solutions to both developmental and strategic issues in your biosimilar or improved biologics (biobetters) program and help you to understand what makes a successful biosimilars or biobetter application. The extensive experience of Accelsiors in the development and registration of both biosimilars and biobetters, make us one of the few companies that truly understand the regulations, the opportunities and the challenges in the field. Biosimilar development requires a holistic approach irrespective of whether it is a simple follow-on polypeptide or a complex mAb or a vaccine, maybe a blood factor or a biobetter. For the success one must be able to translate the CMC particularities into clinical language, or 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 and this is the secret of our success in the biosimilar field.
Combining our proficiency in different therapeutic areas, with well-tailored service capabilities, and access to diverse patient populations, Accelsiors will support every aspect of the clinical and nonclinical development of your biosimilar or biobetter compound – from pre-clinical development trough successful conduct of phase III registration trials to creation of risk management plan for the post marketing risk assessment and beyond.
Accelsiors have got very significant experience in developing of various “Biobetters”, molecules that are modified by protein or glyco-engineering, which are more efficacious, require a 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 biobetters development program.
We are offering the following consultancy services:
- We will help you in understanding what is the legal basis for bio-comparable medicines
- We will help you to figure out what 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 to turn safety challenges of your actual biosimilar into opportunities to create a win-win dimension and strengthen your business
- We will be helping you in outlining the process of developing monoclonal antibody (mAb) biosimilars
- We will point out to you the specific technical issues concerning mAbs, and will be clarifying issues of clinical proofs of similarity
- We will help you to understand the “biobetters” concept and will support you to timely recognize the associated challenges in finding out the best pathways in their development
- We will advise you how best to explore technologies for producing biobetters 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
Through our consultants we will guide you to efficiently analyze the biosimilar-susceptible segment of the global biologic market and get market forecasts for the leading biologics currently susceptible to biosimilar competition.
