A biosimilar is a biological medical product that is claimed to be highly similar to an already approved original biological product...
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A biosimilar is a biological medical product that is claimed to be highly similar to an already approved original biological product (known as a reference product). With expiry of patents on many top revenue biological medicines, there is an increasing interest in biosimilars for biopharmaceutical manufacturers.
Compared with its reference product, a biosimilar product does not need to be taken through the discovery stage and phase II clinical stage, meaning the cost is quite reduced. However, it is not an easy thing to develop and manufacture biosimilars. Unlike generics manufactured simply by chemical synthesis, biosimilars are produced from living cells due to their larger size and more complex structures. Since some of the manufacturing details of the reference product are not disclosed, the biosimilar manufacturers have to develop their own cell clones and manufacturing processes.
The development process of biosimilars involves: 1) selection of a reference product that is off patent (hormone/cytokine/antibody); 2) in-depth analysis of the reference product to obtain the critical quality attributes (CQAs); 3) development of a manufacturing process to match the CQAs of the reference product involving cell line establishment and optimization, protein purification, rigorous similarity evaluations between the reference product and the biosimilar etc.
The variation of each step could modify the final product, thus it is currently impossible to produce the same copies of large proteins from different cell clones and manufacturing processes.
It is important to find a partner that has plenty of experience and experts on the biosimilar field.
Creative Biogene provides integrated solutions for your biosimilar projects. Our state-of-the-art facilities, the best scientists and technologies, regulatory expertise, combined with experience working with stable cell line generation and drug discovery, enable us to be an ideal partner to develop and deliver stable, high producing, functionally characterized biosimilar cell lines. It is important to demonstrate the comparability of a biosimilar to its corresponding reference product. We also possess robust expertise in performing comparibility analyses under non-GLP, GLP and GMP regulations.
Creative Biogene is your reliable partner for developing stable cell lines of following biosimilars:
|Generic name||Brand name||Target|
|Omalizumab||Xolair||IgE Fc region|
|Palivizumab||Synagis||RSV protein F|
|Rituximab||Rituxan / MabThera||CD20|
|Epoetin alpha||Epogen / Procrit|
|Exenatide||Byetta / Bydureon||-|
|Filgrastim||Neupogen / Zarxio||-|