Follow-on biologics, which include BioBetters and biosimilars, are approved subsequent versions of an originator biologic molecule. A BioBetters, sometimes used interchangeably with the term biosuperior, is a biological that has been structurally and/or functionally altered to achieve an improved or different clinical performance, compared to an approved reference product. The requirement for “better than” the reference product/originator product is an important differential from biosimilar products, which are structural imitations of the originator, promising the same effect as the originator biological, but at a reduced cost. BioBetters are modification of the originator product accomplished through chemical (eg, polyethylene glycol [PEG]) or molecular (eg, amino acid modifications by recombinant gene technology or site-directed mutagenesis which provide a functional change(s) that include, but are not limited to, increased half-life, reduced toxicity, reduced immunogenicity, and enhanced pharmacodynamic effects.
BioBetters are not actually a new concept, for example, pegylation of existing molecules is a well-known method for extending the half-life of a biologic molecule, which in turn means a reduced dosing schedule for the patient. For example, the first PEGylated version of the interferon alfa (Pegasys®) was approved by the European Medicines Agency in 2002, but it wasn’t until 2007 that the term “BioBetters” was first coined by the CEO (G.V. Prasad) of Dr. Reddys Laboratories at a bioinvestor’s conference.
With the rapid expected growth in the biologics market, Dyadic believes that its C1 technology has the potential to be a safe and efficient expression system that can help speed up the development and production of biologic vaccines and drugs at flexible commercial scales.
In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes C1 can potentially help bring biologic drugs to market faster, in greater volumes and at lower cost to drug developers and manufacturers. This can potentially improve access and reduce costs to patients and the healthcare system, and most importantly save lives.