TABLE 1
EMA guidelines on similar biological medicinal products
Overarching biosimilar guidelines
Similar biological medicinal products www . ema . europa . eu / en / documents / scientific-guideline / guideline-similar-biological-medicinalproducts-rev1 _ en . pdf
Similar biological medicinal products containing biotechnology-derived proteins as active substance : non-clinical and clinical issues www . ema . europa . eu / en / documents / scientific-guideline / guideline-similar-biological-medicinalproducts-containing-biotechnology-derived-proteins-active _ en-2 . pdf
Similar biological medicinal products containing biotechnology-derived proteins as active substance : quality issues www . ema . europa . eu / en / documents / scientific-guideline / guideline-similar-biological-medicinalproducts-containing-biotechnology-derived-proteins-active _ en-0 . pdf
Product-specific biosimilar guidelines
Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor ( Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance : non-clinical and clinical issues ) www . ema . europa . eu / en / documents / scientific-guideline / annex-guideline-similar-biological-medicinalproducts-containing-biotechnology-derived-proteins _ en . pdf Similar medicinal products containing somatropin ( Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance : non-clinical and clinical issues ) www . ema . europa . eu / en / documents / scientific-guideline / annex-guideline-similar-biological-medicinalproducts-containing-biotechnology-derived-proteins _ en-1 . pdf
Non-clinical and clinical development of similar biological medicinal products containing low molecular-weight heparin www . ema . europa . eu / en / documents / scientific-guideline / guideline-non-clinical-clinical-developmentsimilar-biological-medicinal-products-containing-low _ en . pdf
Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues www . ema . europa . eu / en / documents / scientific-guideline / guideline-non-clinical-clinical-developmentsimilar-biological-medicinal-products-containing _ en-0 . pdf
Similar biological medicinal products containing interferon beta www . ema . europa . eu / en / documents / scientific-guideline / guideline-non-clinical-clinical-developmentsimilar-biological-medicinal-products-containing _ en-0 . pdf
monoclonal antibodies . Expertise acquired over the last 10 years has enabled EU regulators to integrate experiencebased knowledge to the initial science-driven concept . 2 Policies for automatic substitution ( on the pharmacy level ) and switches ( on the prescriber ’ s level ) are regulated at the national level of the EU member states .
According to the EMA guidelines and the scientific opinion of the relevant EMA committees , the European Commission granted an EU-wide marketing authorisation for the first biosimilar medicine ( somatropin ) in 2006 . Since then , the EU authorised by the so-called centralised procedure , the highest number of biosimilars worldwide 2 and these early EMA guidelines served as template for biosimilar adoption in Australia , Canada and other countries . 4
Details of the scientific evaluation of each medicine ( including biosimilars ) approved by EMA are found in the European public assessment report ( EPAR ). 7 Details on the biosimilar development , all types of comparability studies , the risk management plan , and scientific rationale for extrapolation are given and are of enormous value to healthcare professionals involved in the decisionmaking process for a specific product within hospitals .
World Health Organization The World Health Organization ( WHO ) adopted guidelines on the evaluation of Similar Biotherapeutic Products ( SBP ) in 2009 8 and which was based on the EMA guidelines and aligned with the International Council of Harmonization ( ICH ) documents . 9 The aim was to provide a globally harmonized foundation for national regulatory authorities to implement approval pathways for safe and effective SBPs . The WHO guidance documents emphasise the demonstration of biosimilarity by comparative structural and functional characterisation , non-clinical , pharmacokinetic , and clinical studies . 8 – 10
USA In 2010 , the US the Food and Drug Administration ( FDA ) was authorised to implement a regulatory approval pathway for biosimilars ( at that time named follow-on biologicals ) and interchangeable biosimilars . The guidance document for the abbreviated approval pathway for biosimilars ( the 351 ( k ) pathway ) regulates the approval of follow-on versions of US FDA approved biologics . 11 Draft guidance was issued in 2019 , 12 after which the guidance was updated . Critical attributes are
12 | hospitalpharmacyeurope . com