Regulatory Considerations for Biosimilars: Part - I

Yashpal S. Sangwan, Arun Nanda

Abstract: Biotechnological derived products are active substance of a number of biopharmaceutical drugs and have revolutionised the treatment of many diseases. A number of biopharmaceutical patents are due to expire in the next few years, or have already expired. Hence, the subsequent production of follow-on products or biosimilars has aroused interest within the pharmaceutical industry. The potential opportunity for price reductions versus the originator’s biopharmaceuticals remains to be determined, as the advantage of a slightly cheaper price may be outweighed by the hypothetical increased risk of side-effects from biosimilar molecules that are not exact copies of their originators. This review focuses on the issues surrounding biosimilars, including manufacturing, quality control, clinical efficacy and side effects, and how government and industry regulations are evolving to deal with these topics. Part One of the review outlines how biosimilars are different from small-molecule chemical drugs and how copies of biopharmaceuticals cannot be produced in a manner similar to generics. Using approval of Omnitrope as an example, Part One of the review focuses on how European regulators have evolved some guidelines for approval of copies of biopharmaceuticals, or biosimilars, after bogging down in uncertainty for years. Part Two of the review traces the evolution of regulatory guidelines for biosimilars in United States, using approval of Omnitrope as an example. The emerging trends in regulatory considers for biopharmaceutical in United States have also been reviewed.
A biopharmaceutical (or “biological medical product”) is a pharmaceutical product that contains biotechnology-derived proteins as an active substance. Biopharmaceuticals are reported to make up some 10 per cent of the pharmaceuticals market, with many new products in the pipeline. Sales of biopharmaceuticals currently amount to over $ 30 billion in the United States alone. This figure is increasing as other complex biological medicines are being manufactured and marketed to help in the treatment of many diseases. The four main biopharmaceuticals accounting for the majority of sales are epoetin, insulin, growth hormone (GH), and granulocyte colony stimulating factor (G-CSF), but several other cytokines, antibodies and hormones are also available. Biopharmaceuticals make up a large proportion of new medicines and many are being developed using the same technology that is used to produce vaccines. Advances over the last quarter of a century in recombinant DNA technology have allowed the large-scale manufacture of biologically-engineered proteins within living cells. Many of the patents to these products are now close to expiring or have already expired, and manufacturers of so-called copycat pharmaceuticals are attempting to expedite the production of follow-on biopharmaceuticals, termed biosimilars.

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