Generics are not the only cost savers. The patent expiry on many biological medicines is opening the door to more affordable, life-saving medicines to be produced.
A generic is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. It is an exact copy of brand-name drugs that has the same dosage, intended use, effects, risks, safety and strength as the original. In other words, their pharmacological effects are identical to those of their brand-name counterparts. But at a much more affordable price. Generic medicines cost, on average, between 30% and 80% less than the original.
Biological drugs are large, complex proteins made from living cells through highly complex manufacturing processes. Biosimilars are a close equivalent but not exact copies of biologicals, and are manufactured after the patent for the biological/reference drug ends. To be called a biosimilar drug, it must be shown to be safe, work as well as and work in the same way as its reference drug – the biological. It must also be used in the same way, at the same dose and for the same condition as the reference drug. The cost of manufacturing biological medicines is more expensive than conventional chemically produced medicines and, because biosimilars are close copies, they remain expensive but are still more cost effective than the original. The reason biological copies are called biosimilars is that, unlike generic medicines, the active ingredients are not exactly the same as the original but ‘similar’. It is impossible to make identical copies when ‘translating’ biological molecules from living cells in the laboratory. Even though biosimilars are not a direct copy, the therapeutic effect is the same as the original biological product.
Why are generics and biosimilars less expensive?
Generics: Patents are valid for about 20 years – which means that only the approved company may research, create a new formulation and register the medicine.
This takes years and carries a huge financial burden. After about eight to 10 years on
the market, the patent usually expires and other drug companies can make an exact copy of the drug without the initial clinical research costs.
Biosimilars: The research and development expenses, including the costs of highly skilled scientists, clinical trials and the specialised equipment needed, are the main cost drivers. Companies are required to fund these costs, often in excess of 10 years, before registration for use by patients.
Biosimilars save costs because the molecule and effects have already been discovered and identified by the originator. The number of patients required in the clinical trials is also reduced. The original biological medicine would have been ‘manufactured’ at least 20 years ago and new manufacturing methods are more efficient. The cost-efficiencies of generic and biosimilar medicines is assuming greater importance for state and private health funders as populations age and the prevalence of cancers and other non-communicable diseases increase.
Source: Bonitas Medical Aid