Bringing biosimilars to market more quickly
The development of biosimilars is a complex process that can take several years. However, there are a number of things that can be done to accelerate the biosimilar development process, including:
- Streamlining the regulatory approval process: Regulatory agencies are working to streamline the approval process for biosimilars, making it possible for biosimilars to come to market more quickly.
- Investing in new technologies: New technologies are being developed to improve the efficiency of biosimilar development. For example, new analytical methods can help to reduce the time and cost of biosimilarity testing.
- Collaboration between stakeholders: Pharmaceutical companies, contract research organizations (CROs), and clinical trial sites are working together to accelerate the development of biosimilars. By working together, these stakeholders can overcome the challenges of biosimilar development and bring new biosimilars to market more quickly.
Biosimilar development is underway around the world
Understanding the Contrast Between a Reference Biologic and a Biosimilar Product
We are experts in biosimilar development and offer a comprehensive range of services, including cell line development and characterization, clinical trials in diverse disease indications, regulatory guidance, laboratory analysis, and innovative statistical technology to provide the evidence of bioequivalence required for approval.
Our Services Ensure the Approval of Your Biosimilars
Our team of experts from different departments and therapeutic areas will work directly with you throughout your program. This team will provide the insights and strategies you need to optimize your plan and protocol. Together, we will use best practices to shorten timelines and ensure that we collect and deliver the safety and efficacy data required for regulatory approval and market entry of your biosimilar asset.
Services within Biosimilar Development Encompass:
Cell Line Development: We create optimized cell lines for consistent biosimilar production.
Characterization: In-depth analysis confirms biosimilarity to the reference product.
Clinical Expertise: We conduct diverse disease trials for regulatory data.
Regulatory Insights: Our team navigates complex approvals with regulatory knowledge.
Laboratory Analytics: Advanced analysis ensures product quality meets regulations.
Statistical Innovation: Innovative statistics provide essential biologic equivalency evidence.
EXPERIENCE WITH ALL CLINICAL PHASES
At Shen Clinical Services, our seasoned team specializes in biosimilar development, covering every stage from cell line development to clinical trials, regulatory support, and manufacturing. We’re dedicated to delivering high-quality services and facilitating efficient market entry for our clients.
Advantages of working with us:
1. Comprehensive Expertise: Our team offers extensive knowledge across all biosimilar development facets, ensuring a holistic approach to your project.
2. Full-Spectrum Services: We provide end-to-end support, from research to regulatory approval and commercialization.
3. Quality and Innovation: We prioritize quality and continuously explore innovative solutions.
How we can help:
- Cell Line Development and Characterization: We create robust cell lines and ensure regulatory compliance.
- Preclinical and Clinical Pharmacology: We design and execute safety and efficacy studies.
- Clinical Trial Strategy: We assist in designing and conducting trials.
- Regulatory Affairs: We guide you through regulatory processes.
- Manufacturing: We develop compliant manufacturing processes.
- Commercialization: We help you bring your product to market.
Connect with us to accelerate your biosimilar development journey.