Therapeutic Equivalence of Biogenerics: Regulatory and Development Issues (Part-II)

Sanapareddy Eswara Reddy, Manasi Mantri, Prof.(Mrs.) Laxmi Narasu and Prof. J. K. Lalla

Abstract: Part-I of this article entitled ‘Research, Product Development And Production of Biotech Derived Pharmaceuticals’ has been published in October 2007 issue of this journal. The present article covers therapeutic equivalence of biotechnology derived pharmaceuticals. The objective of writing this article is to assist the Pharma and biotech industry in guiding for establishing therapeutic equivalence of Biotech-Derived Pharmaceuticals which need to be produced in India and exported globally. The honorable finance minister Shri P Chidambaram has given incentives in the current budget for the Research areas, 'Biotech-Derived Pharmaceuticals' being the grey area can benefit from this announcement.

This article covers “Regulatory Filing strategies” for biogenerics which may help Indian industry in deciding to invest in biotech industry. The article also emphasizes on Quality aspects of biotech derived Pharmaceuticals which is essential for export promotion.


Biopharmaceuticals are protein molecules derived from recombinant deoxyribonucleic-acid technology (DNA) and the latest hybridoma production techniques, the availability of which has improved treatment options for many diseases. As the costs of these products developed by the innovators are high. This becomes a driving force for increasing the focus on boosting the biosimilar market.

Recombinant technology has provided a means of producing a variety of therapeutic proteins, allowing biopharmaceuticals to become important therapeutic options for a variety of indications. The recent and pending patent expirations for a number of biopharmaceuticals (e.g. granulocyte colony-stimulating factors [G-CSFs], erythropoietin, interferons and human growth hormone) have prompted the study and development of alternative versions of biologic products, referred to as 'biosimilars' or 'follow-on biologics.' Biosimilars are new biopharmaceutical agents that are 'similar' but not identical to a reference biopharmaceutical product. This is unlike the case with generics (small molecule), where the active substance of a generic is identical to the reference product. Characteristics of biopharmaceuticals are closely related to the manufacturing process and incoming material, which cannot be duplicated. Thus, biosimilars are unique molecules and are not generic versions of the innovator biopharmaceuticals.

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