Europe leads the way in the development and commercialization of biosimilar medicines: new licenses and huge savings on the horizon

Europe has taken the lead in the development and commercialization of biosimilar medicines because they have the same effectiveness as biological medicines and can be used in treatment of serious diseases such as cancer, at a much lower cost.

In 2006, the development of biosimilar medicines began, a technology that caused a revolution in the pharmaceutical industry. It has been 12 years since the launch of the first biosimilar, Sandoz´ somatropin, indicated for the treatment of growth hormone secretion deficiency.

Biosimilar drugs are produced from living organisms and have a similar structure to a biological reference; they are not identical copies but similar, and they have the same safety, quality and efficacy as the biological reference. They are regulated by the EU (European Union), and their main advantage lies in their price, on average 30% less than that of biological medicines, which favors the extension of treatments. Biological drugs, produced from living organisms as biotechnology-modified cells, are safe and effective, but too expensive.

Biosimilar drugs may only be produced for sale when the patent of its biological referent expires. Insulin for diabetes, growth hormones, therapeutic alternatives for Chrono’s disease, rheumatoid arthritis, rheumatism or different types of cancer, are those that have reached the market in the version of biosimilars, or they will soon. Herceptin or Trastuzumab, counts with several versions of biosimilars since 2009, and perhaps is the drug with the greatest impact on survival and quality of life of patients with breast cancer. Another potent drug is Rituximab, used in the treatment of chronic lymphocytic leukemia or rheumatoid arthritis.

Between 2009 and 2017, the use of biosimilar drugs represented a saving of 478 million euros to the Spanish National Health System. According to the data provided by BioSim (Spanish Biosimilar Foundation), between 2017 and 2020 and due to the expiration of the patent of biological drugs of enormous use, the savings will be about 2 billion euros per year. This saving would be equivalent to 1.3% of the pharmaceutical expenditure for that period.

In Spain there are now eleven active principles of biosimilars, although their penetration is still low, between 22% and 23%, with a huge difference between hospitals and autonomous communities. A change in mentality in clinicians who are still reluctant to prescribe them, and a greater number of biosimilar options would mean even a lower average price and a greater penetration.

Recently, EMA (European Medicines Agency) has approved Pelgraz (pegfilgrastim) by Accord, a biosimilar granulocyte colony stimulating factor (G-CSF) pegylated. Pelgraz is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients undergoing cytotoxic chemotherapy.

Pegfilgrastim is a long-acting form of filgrastim, an effective and safe biosimilar drug for cancer patients receiving chemotherapy, which stimulates the production of white blood and stem cells. The authorized indications are the same as those of the biological reference medicine. In particular, it is used to prevent chemotherapy-induced neutropenia. The onset of neutropenia may delay or disrupt chemotherapy, which reduces the relative intensity of the dose and decreases the effect of treatment, since completing chemotherapy doses is a key factor in increasing survival rates. It is proven that patients receiving pegfilgrastim have a significantly lower rate of severe neutropenia and are more likely to receive the optimal dose of chemotherapy, thus obtaining better results. Pegfilgrastim is given in a single dose per cycle of chemotherapy, which may reduce the need to control the leukocyte count and patients can avoid daily injections.

Pelgraz is the only biosimilar treatment of pegfilgrastim approved in the EU that has phase III and phase I clinical data as part of its efficacy and safety profile.

The EMA recommends the approval and consequent granting of the commercialization license by the European Commission, of three other pegfilgrastim biosimilars: Pelmeg by Cinfa Biotech, Fulphila by Mylan and Ziextenzo by Sandoz.

Much has changed since the beginnings of biosimilar drugs. Unlike 12 years ago, toxicological studies such as comparability are not currently required once biosimilar drugs had been authorized. In addition, there is no longer a reluctance to accept biosimilars with incomplete clinical development, that is, they are authorized despite not having all the clinical indications. Initially, the professionals were hesitant and worried about not knowing the requirements on which authorization of biosimilar drugs was based. However, as during these years there have been no significant safety problems with biosimilars, this has helped to generate confidence in this type of medicine.

The biosimilars overcame some difficulties while other persist. Migration to treatments with biosimilar drugs, although it has advantages, is not done quickly yet. Biological medicines are not substitutable automatically, so if a patient is well controlled with a certain medication, it is not replaced or exchanged immediately. In this context, the criterion of the doctor, the price of the medicines and the doctor-patient decision come into play, since it is an agreed decision between all the parties involved.

One of the future challenges regarding to this new technology, will be to develop biosimilars with better structural characterization and biological activity. For example, the smallest and well-characterized proteins, such as insulin, growth hormone or filgrastim, will be accepted without a chemical comparability test, as long as the aspects of quality, in vitro activity and PK / PD studies are well resolved.

Biosimilar drugs represent a great saving of money for the National Health System, an increase in competitiveness, a possibility that patients can Access to innovative treatments of equal efficacy, quality and safety that biological ones, but with the relief and tranquility that their pockets will not be left with a great debt.

Did you know about the use of biosimilar medicines as an economic therapeutic alternative?If your doctor suggests you treat your disease with this innovative technology, would you accept or continue with the previous treatment for fear or distrust of its effectiveness?

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