Biosimilars
Biopharmaceutical medicines already play a critical role in the effective treatment of many serious diseases and their importance continues to grow. Affordable follow-on versions of several such medicines already exist across the European Union and are leading to increased competition and significant savings for both patients and payers. They are approved as biosimilars by the European Commission, on the recommendation of its scientific advisory body, the European Medicines Agency (EMEA), under the existing centralized procedure. Approval is granted on the basis that they have demonstrated comparable quality, safety and efficacy to the reference product.
All biopharmaceutical medicines, including the reference product, are produced from living organisms and are therefore sensitive to manufacturing changes. Biosimilars are approved with the same scientific rigour, using the same regulatory standards as applicable to their reference products. Prior to approval, they undergo rigorous clinical and other testing, and substantial post-marketing studies are also required as a condition of approval.
Biosimilars increase patients’ access to vitally important medicines by offering comparable therapeutic benefit at a lower price than the reference product. The development and use of biosimilars will allow more patients to be treated for the same cost - a critically important issue when health budgets are limited and demand is increasing.
Because of their relative complexity and the resulting need for extensive development costs, biosimilars may not offer the same level of percentage price reductions compared to reference products as do some generic medicines. However, since the total cost of most biopharmaceuticals is much greater than of many conventional medicines, the total savings to the NHS will be considerable. The introduction of biosimilars is bringing genuine competition to a sector that has until recently been unhealthily short of it.
