By Rodeina Challand, Executive Director, Biosimilars Development, Scientific Affairs, PRA Health Sciences
Governments, healthcare payers, and social and health reforms, combined with the increased incidence of conditions such as cancer and diabetes are paving the way for increased uptake of biologic medicines in emerging markets. However, expensive biologic medicines can be prohibitive to many patients, creating a high level of unmet clinical need. At its best, the global expansion of biosimilars can mean a robust and steady supply of existing and new drugs reaching far-flung patient populations, but localized biosimilar drug developments, especially in China and India, combined with a lack of robust pharmacovigilance systems, threaten to derail the industry by putting patient health at risk.
It’s a chilling fact: One irresponsible company could seriously damage, or even destroy the biosimilar field. A single company cutting corners with under-regulated, lower-quality development could create an inferior product that harms or kills patients. In that instance, news media reports marked by huge headlines might quickly focus on the entire biosimilar industry instead of a single company. The results would be devastating for the industry as a whole and the patients who benefit from its accessible, and generally much-less expensive products.
Regulators across the globe have a duty to ensure the sustainability of biosimilars.
Harmonized definitions are of critical importance because any “fuzziness” can confuse people outside of the industry when published reports are mistakenly construed as a criticism of biosimilars. In many cases, they are talking about