BioBetters are updated or modified versions of currently marketed and approved biologics that, after alteration, produce drugs with improved selectivity, stability, and toxicity. Because of better research and a wider range of technologies available to make therapeutically enhanced products while taking into account higher safety, increased bioavailability, longer half-life, better efficacy, and immunogenicity, BioBetters are bio superior to licenced biologics. BioBetters have an advantage over biosimilars because, as previously stated, they can obtain patent protection if they can demonstrate a significant improvement over the original and biosimilar competitors’ technologies.

However, it may not be possible to patent all BioBetters as the active ingredient is mostly similar to innovator products, unless proven certain significant advantages. Unlike Biosimilars , which are substantially comparable to an approved reference product, a BIOBETTER has the same molecular target and structural elements as the reference products but a better structure or formulation that makes it clinically superior. Biosimilars, as the name implies, will have similar safety and efficacy profiles as reference drugs and are extremely similar to innovator products.

Biosimilars are only allowed after establishing resemblance to the reference product, as well as having the same active ingredient as the reference product. Biosimilars are not eligible for patent protection or data exclusivity. BioBetters, which are modified versions of biologics, should have higher safety and efficacy than reference products. Biosimilars and BioBetters are both variations on the original biological molecule. While a BioBetter must distinguish itself from the original as depicted in Figure 1.

BioBetters show a number of advantages over biosimilars, they are patentable; because of the validated target, they have a better success rate; these are modified versions of original biologic with much reduced side effects profile; risk of failure is comparatively lower than the newest drug; lower early-stage R&D costs and having data exclusivity of 12 years in the United States.

A BioBetter must demonstrate a considerable improvement in one or more features over the original biologic, such as a different mode of administration, a lower side effect profile, improved action, dosage frequency, and so on as given in Table 1.

Biosimilar BioBetter Similar active substance as that of reference product. No structural limitations. It can have different active compounds. Similar safety and efficacy data. Improved safety and efficacy profiles. Approved by demonstrating bio similarity. By submitting all clinical and non-clinical data, approved either through NDA or hybrid application. Neither data exclusivity nor patent protection. Chances of patent or data exclusivity based on innovation. Table 1:

Differences between a Biosimilars and BioBetters.