The Biggest Driver of High Drug Prices: Biologics

(DGIwire) – In 2017, biologic drugs represented two percent of all U.S. prescriptions but 37 percent of all drug spending, according to data from the IQVIA Institute. Furthermore, since 2014, biologics have accounted for nearly all the growth in drug spending: 93 percent of it. What accounts for these incredible figures? A recent article in Forbes accounted for the dizzying set of factors driving the economics of biologic drugs, which are large molecules manufactured in living cells by relatively costly processes.

“The outsize cost of biologic drugs—the need for which is growing ever larger—is putting a severe strain on patient populations and payors alike,” says Mark Emalfarb, CEO of Dyadic International. “Streamlined methods of drug production, such as our C1 vaccine and drug development and manufacturing expression platform, could go far toward alleviating a rapidly spiraling crisis while putting drugs into the hands of those who need them faster and more affordably.”

Dyadic believes that the C1 technology represents an advance over other commonly used cell lines such as Chinese hamster ovary (CHO), E. coli, insect cells such as baculovirus and yeast, which for decades have been the industry standard cell lines used to produce biologics. According to Emalfarb, prominent among the promising alternatives to these commonly used cell lines is Dyadic’s own proprietary protein expression platform, which is based on the company’s proprietary genetically modified strain of fungus: Myceliophthora thermophila, named C1.

C1 has shown promise in producing certain enzymes and other proteins in a shorter amount of time, in higher amounts and at a lower cost than these traditional cell lines. The potential efficiency of C1 as a protein production platform is significant, says Emalfarb. For example, the fungus’ unique shape translates into better growth conditions with higher yields of secreted protein and lower viscosity. In addition to requiring only low-cost synthetic media, C1 is also virus-free, eliminating the need for viral inactivation.

Additionally, the C1 fermentation cycle time is in the range of four to seven days, which is about one-half to one-third the time required by CHO. This translates into a lower production cost both in terms of capital expenditure and operating expenditure, whether a facility uses 12,000-liter stainless steel fermenters or 2,000-liter or smaller single-use bioreactors. Capital expenditure is reduced by C1’s ability to produce biologic vaccines and drugs at higher yields in a shorter time at flexible commercial scales.

“The C1 platform could be among the viable solutions to ensure that global health needs are met by drug manufacturers in both the developed and developing worlds,” Emalfarb adds.