Biologics & Biosimilars
Providing support through all the biologics and biosimilar’s development process
From R&D to post-launch activities, the clinical development process of biologics and biosimilars products can become very demanding. To avoid any hurdle in this process, Eurotrials developed a range of solutions to guarantee the expertise, technology and data you need in your project, from the protocol design, regulatory submission, project implementation to data report.
Biologics Clinical Development Expertise
Clinical development of biologic products is characterized by its regulatory complexity as well as considerable challenges unseen in traditional product development.
Biologics trials demand high vigilance for safety issues, as well as efficient recruitment of specialized patients, as it targets specific diseases. Eurotrials has the necessary capabilities to face the clinical and operational issues involved in biologic products clinical development. Our team brings two decades of experience at every stage of the biologic regulatory and product development process, from design and evaluation of clinical trials to post-marketing and observational studies.
Biosimilar Market Growth
Given the considerable initial investment of the drug during development stages, the opportunities arising from the biosimilars global market are wide, although these risks involved are still elevated.
Regulatory entities evaluate the clinical development process based on the similarity between biologics and biosimilars. This process allows the production of medicines with lower requirements from the regulatory and clinical testing.
Biosmilars require secure strategies and expertise in all drug development phases
A trustable contract research organization (CRO) with expertise in biosimilars’ development is key for its successful regulatory approval in a cost-effective timeline. Since the uniqueness of this development process requires a precise strategic plan, Eurotrials project management expertise will enable regulatory approval and meet your marketing objectives.
Selecting the right markets to develop your biosimilars project
Eurotrials can help you choose the best countries and sites for your biosimilar study.
Biosimilar trials in Latin America can be very attractive for several reasons: increasing interest from local governments, lower costs and broaden patient access. All the legislations necessary to conduct a biosimilar trial in the region is implemented today, although varying from country to country. A partner with strong local expertise is crucial for the achievement of market access success for your biosimilar.
Eurotrials has experience in biosimilars development studies, leveraging the advantages of 20 years in the business. The company acts in both phases of the biosimilars clinical studies – Phase I, to prove similar pharmacokinetics and pharmacodynamics, and Phase III, a pivotal study to demonstrate the efficacy, safety and immunogenicity to the respective biologic.