BIOSIMILARS

The demand for biologic drugs continues to expand due to their effectiveness, along with the increasing occurrence of different diseases as the world’s population lives longer. There is increasing pressure to decrease healthcare expenditures, and to provide more affordable access and costs to healthcare systems and patients. With the accelerated advances in genomics, and biotechnology continuing positive outcomes in ongoing clinical trials are expected, this coupled with the rising demand in various therapeutic applications are just some of the contributing factors for the emerging adoption and anticipated growth of the biosimilars market.

There are an increasing number of biologics losing their market exclusivity. It is anticipated that by the end of 2019, 39 biologics, with combined US sales of $41 billion, representing 30% of the current biologic market, will lose their marketing exclusivity. This has resulted in huge interest by big pharma and biotech companies venturing into the Biosimilar sector in order to gain a slice of a multibillion dollar worth of the biologics market. Other factors increasing the demand for biosimilar drugs include rising disease incidences across the globe and better access to healthcare for all nations.

However, circumstances such as complexities in developing molecules that are proved to be similar to the original drugs and costs, rigorous regulatory requirements in countries, and innovative strategies by biologic drug manufacturers restricting the entry of new players are restraining the growth of this market.

With the anticipated rapid 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 certain 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.

 

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Tab 1 Vaccines