Topic 16- Quiz 4
developed using unique biological systems and living cells
biosimilars
generics for biotechnology products
biosimilars
require high investment -clinical trials, post-approval safety monitoring
biosimilars
analytical, non-clinical, and clinical data needs to be ________ to original biologic in terms of structural characteristics, safety and efficacy
similar
can small molecule medicines be exactly reproduced?
yes, because they are produced through a chemical process, they can be copied exactly. small molecule medicines can be replicated as generics of an original brand name medicines, where they share the exact same active ingredient and are therefore bioequivalent
insulin glargine
Basaglar
latest biosimilar approved by FDA as a biosimilar in July 2020 for adalimumab -reference product Humira
Hulio
latest biosimilar approved by FDA as a biosimilar in June 2019 -reference product Herceptin
Kanjinti
first biosimilar approved in the US, added to FDA's new purple book in March 6th, 2015
Zarxio
for a biological medicine with a protein as the active substance, the ____________ of the biosimilar medicine is expected to be the same as that of the reference product
amino acid sequence
a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product
definition of a biosimilar by EMA
a biological product that is highly similar to a US licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and. potency of the product
definition of a biosimilar by US FDA
a biotherapeutic product which is similar in terms of quality, safety, and efficacy to an already licensed biotherapeutic product
definition of a biosimilar by WHO
FDA has issued draft guidance on biosimilar __________, but as of February 2021, no FDA approved biosimilars have achieved this designation
interchangeability
the practice of dispensing a biosimilar instead of the reference medicine by a pharmacist without consultation from a prescribing physician is currently prohibited in most markets
interchangeability
can large molecule medicines be exactly reproduced?
no, because they are derived from living cells, biologics can never be exactly reproduced or copied like generics. however, a biosimilar version can be produced to be highly similar to the original in terms of safety, purity, and potency, and used to treat the same illness or condition as the original
biosimilars not likely/likely to be identical to the original biologic
not likely (similar, but not the same)
approved drug products with therapeutic equivalence evaluations
the orange book
also contains info about all FDA licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the CDER
the purple book
database contains information on all FDA licensed, approved biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products and their reference products
the purple book
lists of licensed biological products with reference product exclusivity and biosimilarity or interchangeability evaluations
the purple book