What are biosimilars?
Biosimilars are versions of drugs that are made to be identical or similar to drugs that already available on the market – also known as originators, innovators or reference medicinal products (RMPs). Due to clearer regulatory guidelines and better uptake in the industry, the biosimilar market size is set to increase considerably over the coming decade.
Biosimilar development and manufacture can begin once the market patent associated with the innovator has expired. Once this development begins and biosimilar drug material is manufactured, biosimilar testing must take place. This involves comparing the biosimilar to the innovator product across various parameters in order to prove it is similar to the innovator.
Examples of Biosimilars Tested in BioPharmaSpec Laboratories
- Actemra (Tocilizumab biosimilar)
- Avastin (Bevacizumab biosimilar)
- Enbrel (Etanercept biosimilar)
- Erbitux (Cetuximab biosimilar)
- Erythropoietin and Darbepoetin
- Eyelea (Aflibercept biosimilar)
- Filgrastim (G-CSF and PEGylated G-CSF)
- Glatiramer Acetate
- Herceptin (Trastuzumab biosimilar)
- Humira (Adalimumab biosimilar)
- Insulin and Insulin Analogs
- Lucentis (Ranibizumab biosimilar)
- Prolia (Denosumab biosimilar)
- Remicade/ Remsima/ Inflectra (Infliximab biosimilar)
- Repatha (Evolocumab biosimilar)
- Rituxan/ MabThera (Rituximab biosimilar)
- Simponi (Golimumab biosimilar)
- Soliris (Eculizumab biosimilar)
- Stelara (Ustekinumab biosimilar)
- Synagis (Palivizumab biosimilar)
- Xolair (Omalizumab biosimilar)
Biosimilars vs Biobetters
As discussed above, biosimilars are targeted to be identical or highly similar to drugs already on the market. Biobetters are “better” versions of the marketed product. They exhibit some superiority over a marketed drug, such as an improved formulation or structural changes that may lead to better efficacy or safety.
Biosimilar and Biobetter Development
Biosimilar development and approval relies heavily on the data obtained from the protein characterization and comparability studies that have been performed on the biosimilar and the originator. For traditional recombinant proteins, much more emphasis is placed on the clinical studies. Therefore, it is important to plan effective biosimilar comparability and characterization studies, which assess all structural, physicochemical, biophysical and functional attributes.
Biobetters are treated as new drugs by the regulators and therefore have the additional regulatory requirements over biosimilars. However, the active drug is still well known and therefore development time and costs should be lower than with a new drug. Some companies have even opted developed a biobetter to their own marketed product, in order to maintain market share and protect themselves against potential biosimilars.
Our Approach to Testing
As part of a wide range of protein characterization services, BioPharmaSpec provides a comprehensive package of testing including biosimilarity, comparability and characterization studies to support our clients who are developing biosimilars.
BioPharmaSpec meets the requirements of regulatory guidelines through biosimilar testing (e.g. biosimilarity, comparability and characterization studies) of both the biosimilar drugs and the innovators. These studies cover the protein characterization methods suggested in various biosimilar guidelines including:
- Primary de novo Amino Acid sequencing
- N and C Terminal Sequencing
- Amino Acid analysis
- Peptide mapping
- Disulfide bridge analysis
- Intact molecular weight
- Carbohydrate, Glycosylation and Glycan Analysis
- icIEF and CE-SDS
- Liquid and Spectroscopic Profiling
- Higher Order Structure
- Host Cell Protein Analysis
Need Biosimilar Testing?
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.