Biosimilar Development Solution

Linical Solutions

Biosimilars Development

Your Partner in Biosimilars Development

Biosimilars mean an increasing opportunity for drug developers but their way to the market involves facing a changing regulatory framework and a complex development process. To successfully navigate these key issues sponsors must work together with an experienced partner.

Linical has the expertise, reach and capabilities to provide full support in biosimilars development. We understand the challenges associated with biosimilars and work with sponsors to ensure the success of the programs.

Our services cover the complete range of Biosimilar development

Regulatory Affairs
Consulting

Insights to successfully navigate Biosimilars’ regulatory environment.

Clinical Development
Design

Lean and flexible development plans to ensure operational effectiveness.

Phase III
Clinical Trials

Full service, global reach, data driven country and site selection with experience in related indications

Bioanalytical
Support

Partnership with best-in-class global labs with extensive experience.

Wide Experience in Clinical Trials with Biologics, Supporting Our Clients for More Than 10 Years

Our work spans through main therapeutic areas (Oncology, Haematology, infectious disease, Gastroenterology…) and key indications

All phases with significant experience in Phase III

Worked in main European territories and have an outstanding experience in key markets in Asia with successfully completed Biologic trials in Japan, Korea or Taiwan.

Optimizing your
Biosimilar program

With a flexible approach our team designs strategies to minimize risks and bring Biosimilars to the market in the most cost-effective way possible

Boost your Biosimilar Development

With the right size, right reach and right team, Linical can help you navigate the most complex
aspects related to biosimilars

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Resources

Optimizing Biosimilars Development

17 March, 2022

Optimizing Biosimilars Development: Accelerating development and reducing its costs must be among strategic considerations for Biosimilars companies.