Product-specific biosimilar guidelines ( continued )
Non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha www . ema . europa . eu / en / documents / scientific-guideline / reflection-paper-non-clinical-clinicaldevelopment-similar-medicinal-products-containing-recombinant _ en . pdf
Similar biological medicinal products containing recombinant erythropoietins www . ema . europa . eu / en / documents / scientific-guideline / guideline-non-clinical-clinical-developmentsimilar-biological-medicinal-products-containing _ en-1 . pdf
Similar biological medicinal products containing recombinant follicle-stimulating hormone www . ema . europa . eu / en / documents / scientific-guideline / guideline-non-clinical-clinical-developmentsimilar-biological-medicinal-products-containing _ en . pdf
Similar biological medicinal products containing monoclonal antibodies : non-clinical and clinical issues www . ema . europa . eu / en / documents / scientific-guideline / guideline-similar-biological-medicinalproducts-containing-monoclonal-antibodies-non-clinical _ en . pdf
Other guidelines relevant for biosimilars
Comparability of biotechnology-derived medicinal products after a change in the manufacturing process – non-clinical and clinical issues www . ema . europa . eu / en / documents / scientific-guideline / guideline-comparability-biotechnologyderived-medicinal-products-after-change-manufacturing-process _ en . pdf ICH Q5E Biotechnological / biological products subject to changes in their manufacturing process : comparability of biotechnological / biological products www . ema . europa . eu / en / documents / scientific-guideline / ich-q-5-e-comparability-biotechnological / biological-products-step-5 _ en . pdf
Immunogenicity assessment of biotechnology derived therapeutic proteins www . ema . europa . eu / en / immunogenicity-assessment-biotechnology-derived-therapeutic-proteins
Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use www . ema . europa . eu / en / documents / scientific-guideline / guideline-immunogenicity-assessmentmonoclonal-antibodies-intended-vivo-clinical-use _ en . pdf
What are the key pharmacokinetic considerations in the assessment of biosimilarity ? www . ema . europa . eu / en / human-regulatory / research-development / scientific-guidelines / clinicalpharmacology-pharmacokinetics / clinical-pharmacology-pharmacokinetics-questions-answers # 7 . - biosimilars-section
defined for each molecule and the CQAs of biosimilars should fall within the same specifications as the reference biologic . 12 When physicochemical similarity is given , additional animal and clinical studies assessing biosimilarity are necessary . The clinical trials should assure that there are no meaningful differences between the biosimilar and the RP . 12 With differing patent periods for RPs in each country , the marketing authorisation dates of biosimilar molecules are often different in the US and Europe . Although there is an additional guideline for interchangeable biosimilars which permits automatic substitution at the pharmacy level in some European member states , no such approval is currently granted in the US . The interchangeability status can be achieved based in post-marketing surveillance data and at least one prospective controlled switching study with at least three switches in the switching arm . 12
Asia and Latin America Between 2008 and 2015 numerous countries in Asia ( e . g ., Japan , South Korea , India , China ) and Latin America ( e . g ., Argentina , Brazil ) adopted regulatory guidelines for biosimilars based on the EMA and / or WHO , and / or US FDA guidelines and the principles of comparability and biosimilarity to already approved reference products . 4 The maximum numbers of monoclonal antibodies ( mAb ) as well as non-mAb biosimilars received marketing authorisation in Asia , followed by Latin America , Europe , and North America . 4
Table 2 summarises the main regulatory documents and frameworks .
Conclusions Europe led the way some 20 years ago with regulatory guidelines for the development and authorisation of biosimilars ( authorised after license expiration of the biological RP ) and which were subsequently implemented in most healthcare systems around the world . The development route for biosimilars requires comparative clinical trial with the RPs for one selected indication and safety and efficacy data can be extrapolated for indications already approved for the reference medicine . Pharmacovigilance is still required for biosimilars but this becomes more difficult in countries where automatic substitution at the pharmacy level is permitted . hospitalpharmacyeurope . com | 13