Regulatory Considerations for Biosimilars - Part Two

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.

Biosimilars or Follow-on biologics are terms used to describe officially approved new versions of innovator biopharmaceutical products, following patent expiry. Biosimilar is the term coined for protein drugs that are similar, but not identical to, existing product. Unlike the situation with non protein drugs it is not possible to create an identical copy or 'generics' of biological drugs: this is mainly due to the complex nature of protein molecule. The fact that biosimilars are not perfect copies of originators drugs they are created to resemble has raised a series of questions concerning their regulation, quality, safety. The term “biosimilar medicine” comes from EU legislation governing the approval process, but these products are also known as “similar biological medicinal products”, “follow-on biologics” and “biogenerics”. Biosimilars are the closest thing that the biotech world has to generic drugs. However, because biotech drugs are grown in cultures, rather than constructed out of chemicals like traditional pharma drugs, it is impossible to have a generic version of a biotech drug that is an exact reproduction of the original. This makes biosimilars difficult.


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