Cheap and effective: generic or bioequivalent drugs. But what a struggle for their affirmation!

We talked to Prof. Silvio Festinese, Lecturer in Pharmacology at UniCamillus University

 They cost less than their ‘brand-name cousins’, boast the same therapeutic efficacy, are equally subject to strict controls, and are available even for less common diseases, as well as for chronic ones, where a certain continuity of treatment is required.

Despite all these advantages, generics still struggle to enter the hearts of Italians, but also to hold their own in the difficult pharmaceutical market.

One of the main problems concerns public perception: many patients are prejudiced about their efficacy and safety compared to brand-name drugs. Research conducted by Elma Research, released in 2022, found that people perceive the lower price as a connotation of lower value, as well as perceiving the adjective ‘generic’ as ‘approximate’, rather than with its real meaning of ‘unbranded’.

In addition to a misinterpreted semiological yardstick, other issues undermine the path of generic drugs. These include competition with brand-name drugs ecoming fierce: a survey by ICE Italian Trade & Investment Agency, published in January 2023, reports that the average profit for generics has fallen from 9% in 2016 to 7% in 2021.

Given these difficulties in terms of competition and consumer acceptance, it is not difficult to guess that the problems that have affected the pharmaceutical sector over the last period have had the greatest impact on generic drugs. This is shown by the 2023 edition of the Egualia report, produced by the Nomisma Observatory.

From this analysis, it emerges that there is a shortage of supply of active ingredients because we are largely dependent on China and India, which supply Europe with more than 56% of the ingredients. Partly for this reason, Europe is facing an increase in pharmaceutical expenditure. According to Medicines for Europe, an association of biosimilars companies, by 2022 prices have increased by 500% for transport, 65% for gas, 30% for electricity, between 50% and 160% for raw materials and between 20% and 33% for packaging (as reported by AboutPharma).

For months, the Italian government has been conducting round tables and initiatives to help generic drug manufacturers maintain the availability of their products on the market. Among the various measures, we find the ‘Filiere produttive’ (tr.Production Chains) desk, activated at the turn of the summer and autumn of 2023, which had an endowment of EUR 391.8 million and was open to the submission of applications under the Contratti di Sviluppo framework, thus supporting strategic industrial programmes, including those in the chemical and pharmaceutical sector.

The issue surrounding generic drugs is complex, as it is affected by political dynamics, the international market and public confidence. For this reason, we asked Prof. Silvio Festinese, Lecturer in Pharmacology at UniCamillus University.

Is there resistance towards generic drugs? Why? Are they not as effective and safe as the brand-name ones? What are the differences in terms of bioavailability?

“Today in Italy, generic drugs, after their introduction in 1996 (financial law), are prescribed on average in about 30% of cases (44% in the north; 33% in the centre; 24% in the south), compared to about 65% in English-speaking countries. This data clearly demonstrates a strong distrust of generic drug use some 28 years after their introduction. Every generic drug, in order to be marketed, must undergo bioequivalence studies versus the originator medicine, presenting the same active ingredient and dosage, with the only variation regarding excipients (inert ingredients). The efficacy of the bioequivalent drug is now unanimously proven and recognised in the world of clinical pharmacology: the bioequivalence range varies from +25 to -20% compared to the originator medicine, and the safety of the production procedures overlaps with all other ethical drugs on the market.”

Generic drugs cost less than their brand-name equivalents. This is a benefit for patients. Is it also a benefit for the National Health System?

“Italian patients spend around one billion euros per year in cost-sharing (out-of-pocket), choosing the originator or brand-name drug, with around 190 million euros per year in lost revenue for the public purse.”

Can generic drugs partly buffer the problem of drug shortages, especially of those considered ‘critical’?

“Generic drugs can free up economic resources for regional health budgets, thus coping with the introduction of high-cost innovative drugs.”

What are the regulations governing the production and distribution of generics? Are there adequate controls before they enter the market?

“The controls on correct manufacturing procedures do not change for all drugs on the market and in the medical handbook, and in some cases (e.g. absence of lactose) they may even improve in excipients for intolerant patients.”

Generic drugs, being cheaper, promote accessibility to treatment. This also allows for greater availability of products that can be vital for developing countries and less fortunate contexts: is this correct?

“Yes, it is another advantage. Given the strong cost reduction after patent expiry, many drugs are inevitably more accessible to developing countries.”

In your opinion, what should we focus on so that the general public overcome their prejudices against generics?

“By shifting from pharmaco-economics criteria (ministry) to pure commercialisation criteria (pharmacy), the two-way, privileged doctor-patient relationship has been undermined, and other health figures, other competences, other interests have entered the field. For years, many companies have chosen not to provide scientific drug information to general practitioners and outpatient specialists in the area, all of which has contributed to suspicious prejudices and, above all and unfortunately, a lot of confusion, which is still present today decades after their introduction.”

What aspects do you think need to be improved in the production and marketing of generic drugs?

“Bioequivalent or generic drugs are now produced by several multinational drug companies that market their products so extensively that there are no longer any obstacles to their daily use.”