The Future of Biosimilars and Biobetters

With the latest drugs hitting the market daily, there is a vested interest among pharmaceutical and biotech firms and scientists and physicians to enhance existing biologics.

FREMONT, CA: Biologics medications are created out of proteins, sugars, or DNA and frequently are a complex combination of these materials and by-products. Biologics can also be produced out of living cells and tissues and come in various products like allergy medicines, vaccines, therapeutics, and oncology treatments. Biologics that deploy gene-based technologies are presently leading the charge in biomedical research as the requirement increases to not only cure serious medical conditions but avoid them from occurring in the first place.

Biosimilars are drugs that are similar to biologics. As with any biological medicine, biosimilars are put through the same rigorous testing standards needed to ensure that the pharmaceutical in question is safe and effective. Although some have gone as far as describing biosimilars as a generic part of the reference product, that isn’t completely accurate. There are essential differences between conventional small molecule ‘generic’ medications and their biosimilar counterparts.

There is a novel class of biologics that have entered the market known as ‘biobattery.

[vendor_logo_first]Biobetters are considered the better, new-and-enhanced version of existing biologics. Biobetters are altered to include molecular or chemical modifications to better safety, enhance efficacy, and even mitigate toxicity. The NIH provides a more detailed and technical definition of a biobetter; Biobetters is new drugs developed from existing peptide or protein-powered therapeutics by enhancing their properties like affinity and selectivity target epitope and stability against degradation.

Both biobetters and biosimilars are follow-on biologics. Meaning they are designed and manufactured about an originator biologic. Also known as biosuperiors, biobetters are an enhanced adaptation of the originator biologic, while biosimilars aim to mimic the structure of the originator biologic. A biosimilar is leveraged as a regulatory term. At the same time, a biobetter doesn’t have an accepted definition. While it is presently impossible to precisely replicate an existing biopharmaceutical, biosimilars are as close as firms can get to a carbon copy of the reference product. Even though biosimilars are very ‘similar to the reference product, it is essential to reiterate that they are not duplicates of the originating biologic.

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