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The growing market of biosimilars

According to the annual report published by the Italian trade association Assogenerici on teh sales of equivalent drugs, 2019 was a year of high growth for biosimilars. Not only there are more molecules available compared to the previous year – currently 14 – but their consumption increased of almost 80%.

As known, biosimilar medicines are medicines highly similar to biological medicines (i.e. those derived from microorganisms, animal or human cells) already approved, but whose patent has expired. As it also happens for generics, biosimilars are similar to reference biological drugs in terms of quality, efficacy and safety but can differ due to a certain natural variability, based on their complex nature and on the different manufacturing techniques.

Although they are intended for the treatment of common diseases, such as autoimmune diseases and several forms of tumours, and present a more competitive price compared to the originator, the market of biosimilar struggled to take off.

Yet, authorities made every effort, promoting their use as they are more affordable for the national health systems. To this aim, in fact, the European Commission published a guideline of information for health professionals, along with a series of information intended for patients. Also the Italian agency, AIFA, made available several documents on this regards, including a handbook, a safety analysis and two position papers.

However, some regulating provisions “damage” the spreading of biosimilars as they do not facilitate their use. In fact, differently from equivalent drugs, for biosimilars the automatic substitution of the reference drug by pharmacists is not provided for.

The use of a biosimilar drug can occur only by decision of the treating physician, who can however use it both for new patients and for those already receiving another reference product. For this reason, authorities have been promoting the dissemination of information on these drugs to professionals, who are recommended to always discuss the available therapeutic options with the patient.

The increase observed in 2019 has possibly taken advantage of the option to use not only a fantasy name but also the name of the active substance followed by the trademark/MA holder to name the drugs. The 5 most sold molecules in 2019 were filgrastim (for patients subject to cytotoxic chemotherapy); epoietins (used as anti-tumour drugs); rituximab (to treat leukaemia); infliximab and etanercept (for the treatment of autoimmune diseases).

Therefore, the growing development of biosimilars grants prompt access to drugs for all patients, ensuring not only efficacy, safety and quality, but also sustainability for the National Health System.

Written by: Maria Pia Felici

Foto di Phoenix Locklear da Pixabay