Biosimilars & Biosimilar Testing

Biosimilarity and Comparability Studies

At BioPharmaSpec, we understand that the development and manufacture of any biosimilar can be complicated. Our multidisciplinary team has years of experience in characterizing the structural and physicochemical attributes of originators and biosimilars of many different classes of molecule.

We know the hurdles that can be encountered from early development through to multi-batch comparability studies and routine manufacturing. Working with BioPharmaSpec you will feel confident that your development decisions are based on quality data from a trusted CRO partner.

Biosimilar Drug Product Development

Our Approach to Biosimilar Testing

Working with our scientists you get the support you need with every step of your biosimilar development journey:

  • Originator product characterization
  • Analytical support for clone selection and process development
  • Comprehensive physicochemical characterization to demonstrate biosimilarity
  • Method development, optimization and routine analysis
  • Ongoing consultancy from our scientists to put our structural characterization data into context and support your regulatory package

BioPharmaSpec Biosimilar Experience

Our scientists have a deep understanding of the structure of many different molecule classes and have been involved in hundreds of biosimilar characterization and comparability projects, helping clients accelerate the development of their product.

Monoclonal Antibodies Adalimumab, Trastuzumab, Rituximab, Cetuximab, Nivolumab, Pembrolizumab, Infliximab, Bevacizumab, Natalizumab, Ocrelizumab, Vedolizumab, Tocilizumab, Eculizumab, Golimumab, Ustekinumab, Paliviumab and more
Antibody Drug Conjugates (ADCs) Gemtuzumab ozogamicin (Mylotarg), Brentuximab vedotin (Adcetris), and Trastuzumab emtansine (Kadcyla)
Fusion Proteins Aflibercept, Etanercept and Abatacept
Fab fragments Ranibizumab and Certolizumab
Hormones Teriparatide, Parathyroid hormone (PTH), Erythropoietin (EPO), Darbepoetin (DPO), Insulin and insulin analogs, Human Growth Hormone (hGH) and PEG-hGH and more
Peptides Glatiramer acetate, Linaclotide, Liraglutide, Teriparatide, Exenatide, Lanreotide and more
Cytokines Filgrastim and PEG-Filgrastim, Interferons and PEG-Interferons, Interleukins and more
Other Low Molecular Weight Heparins (LMWH) and more

Need Biosimilar Testing?

There’s no better partner for your project than BioPharmaSpec

BioPharmaSpec scientists provide data to support over biosimilar development programs all over the world. Contact our scientists now with the name of your biosimilar molecule (e.g. Adalimumab, Enbrel, Insulin etc) to receive more information, including quotations for biosimilarity or comparability studies.