This is a question still lingering in the pharmaceutical industry for some time. Biologics/biosimilars are not like the Generic Chemical products, whereby clear equivalence between the generic and originator can be established. Biologic/Biosimilar are a much larger molecular structure. Thus, Biologics/Biosimilar pharmaceutical companies are never able to create an exact replica of the originator’s molecular structure. Variance between both structures will always be there. Nevertheless, the pharmacological action/efficacy of both structures will be always established to be the same as controlled in the product’s clinical studies.
With many potential areas of variances between biologics/biosimilar and originator, it created the question of this article title.
However, with the aim of providing access to a larger group of patients and competitive pricing compared to the originator, more and more biologics/biosimilars were developed by companies and used in patients. This established the fact that biologic/biosimilar are indeed equivalent to the originator. Despite no reference authorities having outright stating that biologic/biosimilar are equivalent to originator.
Recently, in September 2022, EMA (European Medicines Agency) issued a statement confirming the statement that “biosimilar medicines approved in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.” This was a landmark statement by a reference authority that would spur more biologic/biosimilar product development.
Regulatory intelligence for a biologic/biosimilar product registration is a far more complex and wide required as compared to the Generics, cosmetic, supplement registrations etc.
We have the necessary team with well established experience in guiding companies for biologic/biosimilar product registration in Malaysia. Call us now for a free short consultation !