Biologic medicines and biosimilars

August 9, 2011 6:00 AM

What is a biological medicine?

A biological medicine is a medicine whose active substance is made by or derived from a living organism. For example, insulin can be produced by a living organism (such as a bacterium or yeast), which has been given the gene that enables it to produce insulin.

What is a biosimilar medicine?

Biosimilars (similar biological medicinal products), follow-on biologics, similar biotherapeutic products or subsequent entry biologics are the terms which are used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different manufacturer following patent and exclusivity expiry on the innovator product.

The active substance of a biosimilar medicine is similar to the one of the biological reference medicine. Biosimilar and biological reference medicines are used, in general, at the same dose to treat the same disease.

Why do we need similar biological medicines?

Biological medicines are the essential part of the pharmaceutical market and the expenditure on biological products are growing. They are more extensive to manufacture and they are more expensive than the conventional, chemical medicines.

Some major biotechnology-derived medicines are already off-patent or will be off-patent in the near future and biosimilar manufacturers have already started manufacturing the similar versions of the biotechnological reference medicines.

With the help of biosimilars, the healthcare costs will be reduced. Biosimilar medicines will be (are already) cheaper than the original reference products and this helps governments to control their healthcare expenditure.


What is the worldwide status of biosimilars?
Biosimilar medicines are a reality in the European Union. Necessary legal framework for biosimilars are already established in the EU and the first biosimilar was approved in April 2006.

The legal pathwork in the US is still under discussion but there are no obstacles for a biosimilar to be registered although there are no specific guidelines published.

Japan, Canada, Singapore, Mexico, Venezuela, Brazil, Columbia, Argentina, Saudi Arabia, Turkey, Australia, Taiwan, Israel, Switzerland, Malaysia and South Korea have also published their biosimilar medicines guidelines and approved some products.

Additionally, WHO (World Health Organization) also published a reference guideline about biosimilars which can be accessed from here. They name the biosimilars as “subsequent entry biologics” and the guideline is mainly similar to the EU guidelines.

Countries like China and India have several copy versions of biological medicines on their market. According to the current global guidelines like EMA or WHO, these products are not accepted as biosimilars. They are not developed in line with the mentioned guidelines and can not be registered in regulated markets like EU, US or Japan.


What about patient safety?
In regulated markets, all pharmaceutical companies are legally required to monitor the use, effects and side effects of the medicines. They have systems to detect, assess and understand the reasons of any adverse reactions seen during the use of medicines.

This system is called “Pharmacovigilance” and as a part of the pharmacovigilance, each manufacturer must have their system approved which is also inspected by the regulatory authorities.

Pharmaceutical companies should continuously evaluate the information on the benefits and risks of their medicines. Therefore, if biosimilars are approved by a “stringent” regulatory authority, patients can be sure that, all safety issues are inspected and evaluated.


What will happen in the near future for biosimilars?
To date, only a few classes of biological medicines were out of patent. Therefore only a few classes of biosimilars are approved in highly regulated markets.

But in the near future, more complex molecules, so called “Monoclonal Antibodies- mAbs” will be off-patent and therefore the market of biosimilars will rapidly grow up.

In this new area, there are lots of players, mainly from India, South Korea and EU. There are tens of biosimilars under development worldwide and more to come in the future.


REMEMBER: For information on a specific medicine or for answers to your own particular health concerns, you should always consult with your doctor or pharmacist for their professional advice. consists of details and information about some products and does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

Sources: EMA, Wikipedia, EGA, WHO



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