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Understanding Biosimilars

About Biosimilars

A fast-growing market

A biosimilar is a biologic medicinal drug that is a copy of a drug made by another company, such as insulin or monoclonal antibodies. Biosimilars can be manufactured once the original drug’s patent has expired, and must go through approval processes that involve citing the original drug.

Unlike generics, biosimilars are not carbon copies of their originators. Because they are made of biological molecules, they are more complex, and typically 10 to 1000 times the size of the small molecules that constitute generic drugs, making it almost impossible to create an exact copy.

Biosimilars can cut the cost of treatments in a similar way to generics; this makes them economically as well as clinically important for healthcare systems and professionals. And this is reflected in the figures – the biosimilars market is set to soar to over $6 billion* in the next five years.

Despite this, familiarity with and knowledge of biosimilars is generally low in the medical community, with 25% of doctors never having heard of them, according to one survey**.  The survey, of 470 physicians across Europe who specialize in nephrology, rheumatology, dermatology, neurology, endocrinology and oncology, also revealed that 54% of respondents have only a basic understanding of biosimilars.


Biosimilars in the medical community


In general, acceptance of biosimilars is low in the medical community, according to a needs assessment performed in line with UEMS guidelines. Understanding is also low, including understanding of efficacy and safety data and of interchangeability, substitution, nomenclature, traceability and pharmacovigilance.

More than half of the European doctors surveyed think two medicines with the same International Non-proprietary Name (INN) are structurally identical and approved for the same purpose.

A similar survey*** of 405 US physicians revealed similar results, showing a lack of knowledge of biosimilars. But 97% of respondents said that continuing education on biosimilars was at least somewhat important, and 75% said it was important or very important to their practice.


Understanding biosimilars


As the name suggests, biosimilars are similar to previously patented medicines, but they are not exact replicas. Because they are different to generics – which are carbon copies of drugs made of small molecules – they follow a different regulatory framework. This is to ensure that they are approved based on sufficient clinical evidence and that efficacy, safety and immunogenicity is measured and appropriate for the approved use.

Although they are structurally and biologically similar to the original drugs, biosimilars may not always work in exactly the same way, or be approved for treating exactly the same indications. This has implications for healthcare professionals, in terms of their interchangeability and substitution – knowing how they work is vital.

The biosimilars market will be worth an estimated $6.22 billion by 2020* – almost three times today’s market of $2.29 billion – making it one of the fastest growing and important markets in healthcare. Given its increasing importance, it is vital that physicians and other healthcare professionals further their understanding and knowledge of biosimilars in the coming years.



*: Biosimilars Market worth $6.22 Billion by 2020. Markets and Markets. Read more

**:ASBM European Prescribers Survey, November 2013. Read more

***: NACCME US survey, May 2013; 24. Read moreOpen survey


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