Biological medicines are products derived from living organisms, used in the treatment of serious diseases such as diabetes, cancer, and autoimmune diseases. The active ingredients in these medicines are more complex, compared to non-biological products, so they require much more development time and cost, which limits patients’ access to treatment. Biosimilar medicines, which have been used in the European Union since 2006, represent a sustainable alternative to reference biological drugs. Indeed, their development is based on scientific knowledge obtained from the originator medicine and does not require any costly clinical trials. As a result, they can be brought to market at a lower price, providing greater accessibility to treatment and reducing costs incurred by health systems, which can reinvest these resources. While they are not identical to reference medicines, they are made using state-of-the-art methodologies, according to strict quality standards. Once approved by the EMA, they are considered safe, effective, and interchangeable with reference medicines unless otherwise documented by the treating physician.
What are biosimilar medicines
The concept of “similar medicinal product” was introduced by Directive 2001/83/EC of November 6, 2001. The term biosimilar refers to a product that is similar in quality, efficacy and safety to a reference biological medicine that has been previously patented and authorised for use within the EU for several years.
The trademark exclusivity of the so-called originator medicine lasts for about 20 years, which is considered sufficient to absorb the high costs of research and marketing. When the patent expires, knowledge about the medicine becomes public knowledge, and it is possible for other pharmaceutical companies to develop biosimilar medicines, which, like equivalent medicines, are intended to provide a cheaper alternative for patients and ensure greater accessibility to treatment, thereby contributing to the sustainability of health care systems. Unlike generic medicines, however, biosimilars are not identical to the originals, but have slight differences “due to a certain degree of natural variability, their complex nature and manufacturing techniques.” For this reason, authorization and marketing procedures are more time-consuming and complex. In fact, the European Medicines Agency (EMA) can approve the new product only when, through extensive scientific evaluations, it is demonstrated that the differences from the originator do not affect its efficacy and safety. In this case, the biosimilar can be considered interchangeable, but not subject to automatic substitution as in the case of equivalent medicines. Substitution of the reference medicine can be made by the pharmacist only after consultation with the treating physician.
IQVIA: stemming the “biosimilar void”
According to The Assessing the biosimilar void report, recently published by the IQVIA Institute, by 2032 110 biological medicines will lose the exclusivity mark, with a total value of about 30 billion. Of the 26 largest-market products, about 1/3 still do not have a biosimilar candidate. The figure is even more critical for medicines with annual sales of less than €500 million, which account for about 76 percent of biological medicines with expiring patents.
To curb the risks of the so-called biosimilar void, the Institute proposes a strategic policy based on the following points:
- detailed assessment of biological medicine groups at risk of limited or no competition, at the European and global level;
- rationalisation of efficacy studies without compromising the demonstration of biosimilarity, reducing costs and development time;
- convergence of Guidelines and regulations for development and marketing;
- incentive programs targeting physicians;
- new public purchasing arrangements to ensure competition and market sustainability.
The market for biosimilars in Italy
According to the OsMed 2022 report, our country still shows a low incidence of spending on equivalent medicines. Italy, however, ranks 1st in Europe for spending on biosimilar medicines (76.4 percent), followed by Britain, Sweden and Spain. “With regard to biosimilars, an increase in the consumption of specialty medicines that have been available the longest and a positive trend for more recently marketed medicines is confirmed” (66.1%, against a European average of 33.2%). Regions showing higher consumption are Marche, Tuscany, Piedmont, Basilicata, Veneto and Campania.
The latest AIFA data, updated to June 2023, show a further increase in consumption, especially for newly marketed products. “Biosimilars constitute, compared to their originators, an additional therapeutic option and allow the treatment of a greater number of patients guaranteeing more health for the same resources. For these reasons, it is essential to promote a constructive dialogue between the physician and the patient on the therapeutic choices available, thus contributing to the education of informed and participating patients.”