Biosimilars

‘Biosimilar’ or ‘Follow-on Biologic’ are terms given to manufactured biological molecules, however due to the complexity of biologics, the product made can only be similar not identical to its reference molecule.

Due to the complexity of such products, there are many issues revolving around it such as immunogenicity, developmental, FDA guidelines and many more. It is critical to make sure your company’s plan to tackle these issues stirs your biosimilars along the right path in order to deliver to them to the global marketplace as fast and as efficiently possible.

QPS has multidisciplinary (preclinical and clinical) experience with all of the biosimilars listed below:

Therapeutic Monoclonal Antibodies
Name Biosimilar Product Development Program Outline
Rituximab Rituximab Biosimilar Development Program Outline
Bevacizumab upon request
Trastuzumab upon request
Cetuximab upon request
Adalimumab upon request
Recombinant Proteins
Name Biosimilar Product Development Program Outline
Filgrastim Filgrastim Biosimilar Development Program Outline
PEG-Filgrastim upon request
Darbepoietin upon request
FSH upon request
Insulin lispro upon request
PTH(1-34) upon request
Low Molecular Weight Heparins
Name Biosimilar Product Development Program Outline
Enoxaparin upon request
Dalteparin upon request

We kindly invite you to put our biosimilar development experience to the test by getting in touch with John Kolman (john.kolman@qps.com) who heads up the multidisciplinary Global Biosimilar Team at QPS.

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