2021 closed in Spain with the commercialization of exactly 35 new active ingredients24 more than in 2020, 11 of which are aimed at the treatment of oncological pathologies or of autoimmune natureand up to 12 new orphan drugs are included.
In addition, the authorization of medicines against COVID-19 has also led to a considerable increase in the group of anti-infectives. Regarding the total volume of available drug presentations, 2021 continued the downward trend for the fifth consecutive year, since 1,136 new presentations were marketed –both new and existing active ingredients– and 1,468 were withdrawn. These are some of the conclusions of the annual report published in the latest issue of the scientific journal “Current Overview of Medicines”, edited by the General Council of Pharmaceutical Colleges.
Regarding the degree of therapeutic innovation, the marketing and use in Spain of the first two drugs for pharmacological prophylaxis of COVID-19 (Comirnaty® and Spikevax®, winners of the 2021 Panorama Award), developed and authorized in less than 1 year from the identification of SARS-CoV-2 as the causal agent, thanks to pioneering adaptive processes in clinical research and evidence review by regulatory agencies.
On the other hand, it is noteworthy that in 2021 six new biosimilar drugs have been marketed in Spain: two of the active ingredient bevacizumab, one of adalimumab, one of trastuzumab, one of pegfilgrastim and one of teriparatide; used in various diseases ranging from different types of cancer, autoimmune diseases or osteoporosis, among others.
In the last 10 years, there has been a slight stabilization in the incorporation of new active ingredients in Spain, which was interrupted by the year 2020 (in which there was less marketing of new active ingredients since records were kept in “Current Panorama of the Medication”), but has recovered in 2021.
In addition, it can be noted that since 2002have been marketed in Spain 105 new active ingredients What orphan drugs, which represents 19% of the new active ingredients incorporated in that period (a total of 545). The trend was slightly upward until 2019 thanks to the 32 new orphan drugs incorporated in the previous 5 years (2015-2019), but was also interrupted in 2020 by the only 2 new active ingredients included in medicines that have been designated as orphans.
Regarding the total number of presentations of existing medicines in Spain, as of December 31, 2021, a total of 18,141 were in a marketing situation. During the last 10 years, 9,373 presentations have been added to the market, which represents 51.7% of the total currently available; however, 10,498 presentations also disappeared, which translates into a net decrease of 1,125 formats in that period.
The trend towards renewal is determined by the increase in the number of discharges compared to previous periods and the gradual stabilization of the number of discharges in the last five years (only interrupted in this 2021), in which there has been a total of 1,125 more discharges how tall