Is the advent of biosimilars affecting the practice of nephrology and the safety of patients?
Low-molecular-weight drugs are classical medicinal pharmaceutical products. Generic drugs are the chemical and therapeutic equivalent of low-molecular-weight drugs whose patent has expired. Biopharmaceuticals are medicinal products developed by means of biotechnological processes such as recombinant DNA, controlled gene expression, antibody methods. Biosimilar or similar biological medicinal products are those that are referenced to an existing product and submitted to regulatory authorities for marketing authorization by an independent applicant after the time of protection of the data has expired for the original product. The terms 'biogeneric', 'second entry biological', 'subsequent entry biological', 'non-patented biological product' and 'multisource product' have also been used for these substances but the EMEA (European Agency for the Evaluation of medicinal products) prefers the term 'biosimilar' (the FDA coined the term 'follow-on biologic'). For nephrologists, who are used to prescribing biopharmaceuticals such as erythropoietin to their patients, the issue of emerging biosimilars is of particular importance. Responsibility exists, therefore, at the highest level to review the safety profile of the biopharmaceutical products and the emerging biosimilar products in terms of efficacy, immunological response and tolerance.
Ronco
Claudio
C
Dipartimento Interaziendale ULSS4-5-6 di Nefrologia Dialisi e Trapianto Renale, Ospedale San Bortolo, Vicenza, Italy.
D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D016568:Drugs, Generic / Q000009:adverse effects / Q000627:therapeutic use*; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008970:Molecular Weight; D011994:Recombinant Proteins
D001688:Biological Products; D016568:Drugs, Generic; D011994:Recombinant Proteins; D004921:Erythropoietin