Biosuperiors may reduce concerns about biosimilar pricing, development costs and patient acceptance

April 3, 2013 9:26 AM

Aegis Therapeutics LLC is a drug delivery technology company commercializing its patented drug delivery and drug formulation technologies through product-specific licenses.

The company issued a press release, giving some information about their new technologies to develop biobetters, which they insist to call as “biosuperiors”.

Concerns about the economic viability of biosimilars center around the high development cost relative to small molecule generics, and the difficulty of demonstrating bioequivalence for these complex molecules. In particular, immunogenicity of biosimilars is an area of increasing vigilance at both the FDA and EMA and poses a major risk for product failure and recall. Failure to demonstrate equivalent, or ideally lower, immunogenicity for a biosimilar is both costly and risky, since development of an unsatisfactory or inconsistent immunogenicity profile during development, or much worse, during post market surveillance, will be economically disastrous, mostly likely requiring costly reformulation and additional clinical studies.

Aegis Therapeutics’ patented ProTek formulation technology provides for biosuperior formulations of biosimilars with no, or greatly reduced, immunogenicity and greater overall stability against aggregation and denaturation. Biosimilar formulations using Aegis’ ProTek excipients as a replacements for polysorbate 80 or 20 (Tween 80 or 20) avoid the oxidative damage caused by the peroxides, epoxy acids, and aldehydes that form spontaneously as the polysorbates oxidize in solution and provide for patent protected “biosuperior” innovator and biosimilar drugs.

According to the information given by Aegis, to date, two Top-10 Big Pharma’s and a Top-5 multinational generics company are developing innovator or biosimilar biotherapeutics employing ProTek as a superior alternative to polysorbates.

 

Source: Aegis Therapeutics press release

 

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