Global Biosimilar Development

Inconsistency in nomenclature used for biosimilars has led to confusion in referring to some products. The confusion over terminology is not just a potential concern for patient safety and efficacy, but also can lead to misconceptions which arise from misleading published reports on apparent problems with biosimilars. Several examples of this have already occurred.

Many terms have been used to describe copy biologics: “follow-on biologics”, “subsequent entry biologic”, “similar biotherapeutic product”, “similar biological medicinal product”, “bio¬generic”, “non-innovator biologic” and “biosimilars”. Not all copy biologics are biosimilars, but all biosimilars are copy biologics.

Biosimilars, by definition, are copy Biologics with a clear and effective regulatory route of approval that requires comparability studies at all stages of development: quality, non-clinical and clinical. The comparability studies required for comparing the innovator reference prod¬uct and the potential biosimilar product are crucial for the regulatory process and guarantee the quality and clinical performance of the biosimilar.

Unfortunately, inconsistency in nomenclature used for biosimilars has led to confusion in referring to some products. The confusion over terminology is not just a potential concern for patient safety and efficacy, but also can lead to misconceptions which arise from misleading published reports on apparent problems with biosimilars. Several examples of this have already occurred.

The most important recent development has been in the US; the legislative route creating biosimilars for the US market was created by the enacted healthcare reform law, the Patient Protection and Affordable Care Act (PPAC Act), signed into law in March 2010. Among other changes, the PPAC Act amends the Public Health Service Act (PHS Act) to create an abbrevi¬ated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to or “interchangeable” with an FDA-approved biological product; Also in the PPAC Act, there is a provision demanding that individuals should take personal responsibil¬ity for paying for their healthcare by obtaining health insurance or pay a fine. The latter was legally challenged as unconstitutional, and on 28 June 2012 the US Supreme Court ruled in favour of the bulk of the PPAC Act, meaning that the biosimilars pathway, which is part of the act, is now also safe.