Biological medicines (sometimes referred to as products of biotechnology) are large molecules which are similar or identical to the proteins and other complex substances already present in the human body. They differ from "traditional medicines", that are small chemicals produced through a reproducible chemical synthesis processes.
Biological medicines are made from living cells or organisms that are genetically modified to produce the desired molecule. This procedure requires several steps and is difficult to reproduce. The final active substance has an inherent degree of minor variability, which must fall within acceptable ranges agreed by regulators to ensure consistent safety, quality and efficacy.
A biosimilar medicine (‘biosimilar’) is a medicine highly similar to another biological medicine already marketed in the EU. Companies can market approved biosimilars once the period of market protection of the reference medicine expires. Since these products have a unique manufacturing process they are called biosimilars and not generics as to reflect their similar but not identical properties. To be introduced into the European Union market, biosimilars undergo the same detailed evaluations as all the other medicinal products within the EU, with particular attention to the characteristics pertaining to their particular manufacturing process.
Biotechnology has been used to produce medicines for several disease areas such as oncology, diabetology (insulin), haematology and auto-immune diseases. For more information on authorised biosimilars refer the EMA’s website. It is expected that biosimilars will be introduced to the market at a lower price than their reference medicine. Thus, they are expected to be less costly for healthcare systems in the EU.
For more detailed information on Biosimilars, refer to EMA’s website.
In addition to the usual criteria for ADR reporting, in the case of suspected adverse reactions relating to biological and biosimilars medicinal products, it is important to include the brand name, active substance and the batch number. To report ADRs (side effects) please click here.
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