Adoption of the World Health Organization "Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)" for the Registration of Biosimilar Products"

I. Rationale

Republic Act No. 3720, otherwise known as the "Foods, Drugs and Devices, and Cosmetic Act" as amended, and Republic Act No. 9711, otherwise known as the "Food and Drug Administration Act of 2009", and its Implementing Rules and Regulations, declare that it is the policy of the state to insure the safety, efficacy and quality of drug supply in the country so as to protect the health of the Filipino people.

Biological medicinal products, or biologics, are drug products derived from living organisms.  Biologics include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins.

Similar Biotherapeutic Products (SBPs) or biosimilars, on the other hand are new biological medicinal products claimed to be similar to an already approved Reference Biotherapeutic Product (RBP).  However, based on the current analytical techniques, due to the complexity of their structures, SBPs made by different manufacturers using different processes cannot be shown to be identical, rather similar at best, wit the RBP.   Unlike the chemically derived medicinal products, which have smaller and simpler molecular structures, the usual generic approach is not applicable for the evaluation of similar biologic products.  Thus, the need for an effective regulatory approach on the registration of similar biological product has increased.

 

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