Biological medicines are, without a doubt, a very positive reality in our health system. They offer patients well-founded hope of recovering their health and doctors a whole therapeutic arsenal to deal with diseases that until recently were serious or fatal. But biologicals are a whole universe with its own identity. Its molecular structure is complex. Its origin, production techniques and highly diverse mechanisms of action.
Biologics require large investments, a long time for research, and numerous clinical trials. For this reason, it is often said that its cost is high. However, such a statement is too simplistic, since in order to adequately assess the cost of these drugs it is necessary to go beyond their direct cost. Other aspects must also be considered, such as its important health results or its contribution to reducing healthcare costs due to admissions and readmissions of patients with pathologies that are costly due to their severity and duration.
It is true that, regardless of this and to reduce costs, the use of biosimilars equating them to the generic drugs. And this despite the fact that they have little or nothing in common. Generics are chemical medicines and exactly reproduce the initial drug, while biosimilars are of biotechnological origin and are never identical to the initial or reference medicines. They are similar, but different.
Despite everything, there are those who equate biosimilars and generics and, going a step further, defend that the reference price system be applied to them in order to reduce costs. Those who hold such a position do not seem to care that it is unreasonable to "construct" homogeneous groups with heterogeneous molecules. The risk to patients that this entails does not need further comment.
"The quality, safety and efficacy of biosimilars is guaranteed by the EMA"
But rejecting the reference price system does not mean that there are no other alternatives to reduce costs. Indeed, once the validity of the initial biological patent has expired, the biosimilars that are authorized will be able to compete on price.
The prices of biosimilar drugsThey can be competitive, although perhaps to a lesser extent than generics. And this, because biosimilars require investments between 75 and 250 million euros, as well as clinical trials for seven or more years. It is an economic effort, much greater than for generics. Therefore the reduction will be able to move within more limited margins.
Thus, once the reference price system has been rejected due to the problems and risks it poses, competition between biologics (of one type or another) should be one of the determining factors for the decisions of health managers, assuming that quality, the safety and efficacy of biosimilars is guaranteed through a rigorous centralized procedure before theEuropean Medicines Agency (EMA).
Clinical practice
But beyond prices and costs, from the perspective of clinical practice, The fundamental thing is to have specific rules for the use of biological and biosimilar medicines by the prescribing physician.
A legal regime is needed that completely excludes the (automatic) substitution, based on price, of an initial biologic with a biosimilar. In any case, the ability of the doctor to make the decision on a case-by-case basis must be protected. Although our legislation already recognizes it as such since 2007, we must reemphasize this point.
In any case, our positive Law has several pending subjects: regulate the factors to be considered for interchangeability; define what is to be understood by continuity in treatment; establish the notification procedure between doctors and pharmacists; inform the patient of the decisions that affect their treatment; ensure equity in patients' access to biologics, regardless of where they live.
These and related issues are already being addressed in France, through a working group in which all interested parties participate. It would be convenient if the same thing were done in Spainto develop, with the greatest possible consensus, article 86.5 of the Law of Guarantees and Rational Use of Medicines and Health Products. In addition, article 93.2 of the same Law would have to be interpreted according to the regulations in order to confirm the exclusion of the reference price system.
In conclusion, Compete transparently in prices and have specific substitution and interchangeability rules are the fundamental keys to facilitating access to biological medicines: to all biological medicines, the initial ones and the like, always taking into account the criteria of the prescribing doctor and the interest of the patient.
Julio Sanchez Fierro
Vice President
Health Advisory Council