Why stop at biosimilar when improvements can be made? Biobetters can be challenging to develop, but offer dual rewards: more effective medicines for patients and valuable intellectual property for the developer.
Darrell Sleep |
Biological drugs have undoubtedly revolutionized treatment (and the pharma industry), but there is a downside – cost. The complex manufacturing processes and quality control required to develop safe and effective biopharma medicines tend to result in expensive final products, causing problems for cash-strapped healthcare systems (and negative media coverage for the industry). Less costly – but therapeutically equivalent – versions of approved biologics are therefore in high demand. This is why biosimilars are well established in Europe, and are making inroads into the US market. But given the highly competitive biosimilar space, many companies are seeking an edge – striving for biobetters.
A biobetter addresses the same target as an existing biopharmaceutical (and usually through the same mode of action), but aims to provide an improvement; for example, by enhancing safety, efficacy, or tolerability, or by offering a better dosing regimen. “Better” can be achieved by making structural changes to the original biologic (through chemical modification, amino acid alteration or protein fusion) or by opting for an improved formulation method, amongst other options.
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