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Integrated Biosimilar Testing Services

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Medicilon has been recognized as one of the top drug discovery Contract Research Organizations (CRO) in China and is managed by a team of scientists with a wealth of experience in US-based pharmaceutical and biotechnology companies. As our areas of expertise and service capabilities continue to expand, more and more pharmaceutical and biotechnology companies have taken advantage of our integrated drug discovery and development services.  Since the founding of our company in 2004, our integrated services across biology, chemistry and preclinical services are uniquely designed to help clients developing their research and discovery programs from the initial idea stage to the IND filing phase. For more details, please click Services from nav button on our website.

biosimilar testing

We are a leading service laboratory focused on the bioanalysis of large molecule drugs. With many years of experience supporting innovator and biosimilar programs, this makes us the ideal development partner. Our integrated biosimilar development platform is based on a step-by-step approach to help you move seamlessly through the critical stages of development – from product characterization and biosafety testing, to full comparability studies and clinical trials, including bioanalytical and bioassay.

Preclinical Services

Biomarker Analysis
Immunogenicity Testing
Bioassay Development

Biosimilars Analysis Services

Biosimilar Studies
Protein Analysis
Stability Testing of Biologics and Biosimilars
Biopharmaceutical Process and Product Related Impurities Analysis
Biologics and Biosimilar Product Release Testing

Medicilon conducts toxicology and efficacy studies in relevant animal models by various routes of administration.  Our expertise covers the full range of in vivo, ex vivo and in vitro assessments required to determine biosimilar toxicity and efficacy, from routine hematology to specialized assays developed specifically for the biosimilars.  The extent of biosimilar preclinical studies and endpoints required may vary, but should involve an assessment of similarity with the innovator drug.

Our experienced team have developed a suite of off-the-shelf assay packages to support biosimilar development to complete comparability studies for a range of biosimilar molecules.

Related Information

What Are Biosimilars?
A biosimilar is a biologic medicine designed with the intent to treat a patient in the same way as an existing biologic therapy. How Biosimilars Are Approved?
In highly regulated markets, biosimilars will be approved based on robust data packages that demonstrate similar patient efficacy and safety profiles as reference products.

The Safety of Biosimilars
Tracking and tracing the use of all biologics, including biosimilars, enhances patient safety. Where there are multiple companies developing a biosimilar of the same reference molecule, distinct non-proprietary names for each of those biosimilars is fundamental to traceability.

The Use of Biosimilars

The use of biosimilars will differ from generics because of their complexity. Each biosimilar represents a distinct therapeutic choice.

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Tel : +86 021 58591500

Tips:  Above is part of Integrated biosimilar testing services and biosimilar drug companies. You can also CONTACT US with any question or enquiry you may have. We will be happy to discuss your needs in detail and design an appropriate plan of action.

Related Articles:

Last week brought the first U.S. launch in a new category called “biosimilars.”

Global Biosimilars Market Value Could Hit $55 Billion

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