BIOSIMILARS: THE PROSPECTS FOR THIS NEW WAVE OF BIOTECH DRUGS

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Abstract

♦ Eight major biologicals are facing combined losses of $15 billion when their patents expire, but the short-term prospects for biosimilars is mixed.

♦ The first biosimilar medicines have been approved in the EU, yet there are still some barriers on the way to market.

♦ Unlike the EMEA, the FDA has not applied comparability guidance to bisoimilars leaving no clear US regulatory pathway for approval of "follow-on" biologics; some observers claim that the agency is waiting for politicians to drive the process.

♦ The technical requirements for innovative product approvals have been harmonized by the ICH and the same now needs to be done for biosimilars.

♦ Eventually biosimilars will become as accepted as chemical generics are today.

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