Biological medicines have revolutionised the treatment of many serious diseases. They are used to treat diseases such as asthma, diabetes and rheumatism as well as many types of cancer.
Biological medicines are an extremely versatile group; their size and complexity vary significantly. Biological medicines are produced in living cells, and therefore the manufacture is more demanding and more costly compared with conventional chemical medicines. Ensuring the high and uniform quality of each medicine batch plays a particularly important role.
Once the patent protection of a biological medicine expires, it is possible to start producing “ new versions” of the same medicine, so-called biosimilars. However, a biological medicine and its biosimilar are not the same medicine, and a biosimilar is not a generic substitute for the original biological medicine or for another biosimilar.
The manufacturing process of biosimilars is equally complex and subject to risks. Therefore, the product development and manufacturing costs of biosimilars are also higher than is the case with generics. The marketing authorisation requirements are also more extensive than those applied to generics even if they are less extensive than the requirements imposed on original innovative biological medicines.
Once the patent protection of an original biological medicine expires and biosimilars start to appear on the market, price competition that tends to lower the therapy costs may start, provided that the preconditions for competition are met, considering for example the size of the market and the medicine price regulation. When treatment costs go down, this will give many more patients the opportunity to benefit from biological medicines.
The savings from price competition also make it possible for the patients to have the novel innovative medicines more rapidly in use, both in hospitals and in outpatient care, reimbursed by the health insurance system. It is important that both the savings from price competition and the incentives for development and introduction to the market of new medicines will be safeguarded in Finland.
For further information please read PIF’s outlines regarding biosimilars (2021)
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