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THE PHARMA REVIEW (JUNE 2008)

Biosimilars

R.K. Rishi

Introduction: Medicinal products developed from biotechnology constitute an essential part of medicines available to the patients today. In fact, biotechnology medicines or medical treatments derived from biotechnology have revolutionized cancer care therapy. They represent significant proportion of the currently available pharmaceuticals. Moreover, approximately one third of products in the drug discovery process are from biotechnology origin. Much of the work is going in the oncology area.

When patent of a drug expires, other companies make copies of drugs (called generic drugs). A generic drug is a copy of brand-name drug in terms of similar dosage, safety, strength, how it is taken, quality, performance and intended use. Before approving a generic drug product, drug regulatory authorities require many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. As for all other medicines, some major biotechnology-derived medicines are, or will soon, no longer be protected by patents and they will become open to development and manufacture by other companies. Such copy of biotechnology medicines is called biosimilars (in Eurpean Union) or biogenerics or biopharmaceutical medicines or biopharmaceuticals or follow-on protein products (in US and Japan) or subsequent-entry biologics (in Canada). Currently, there is controversy over the terminology with a number of terms put forward. European regulatory authorities have adopted the term 'biosimilars,' while the US FDA prefers the term 'follow-on biologics.' However, these terms are not used as synonyms for 'generics,' and already there are efforts going on to prevent classification of these products as 'generics.' In this article, most widely used term biosimilar has been used. Biosimilars are medicines which are similar to the original medicine, but due to the complexity of biotechnology medicines they are not an identical copy of the original product.

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