In Europe, the patents of protein products manufactured using biotechnology started to expire in 2000, and more than 10 will have expired by the end of the decade, including patents for growth hormones, α-, β- and γ-interferon interferon, human insulins, epoetin alfa, interleukin 2, G-CSF, follitropin, streptokinase, and tissue plasminogen activator. As with traditional low-molecular-weight chemically derived pharmaceuticals, this allows the possibility of developing new and cheaper versions of these biopharmaceutical products. However, while the former products are relatively easy to manufacture, the latter ones are much more challenging to produce, for many reasons. Recombinant proteins are large molecules, which have a highly complex three-dimensional structure and are not synthesised in vitro, but produced and secreted by genetically modified cells. During this process, proteins can undergo posttranslational modifications, such as glycosylation, that lead to heterogeneity.
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Generics
News
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
- Revlimid (lenalidomide) generics launch across Europe
Research
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
- Trajectories of prices in generic drug markets
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Biosimilars
News
- FDA approves Zymfentra and advances for Yuflyma in the US
- EC approval of natalizumab, aflibercept and tocilizumab biosimilars
- EMA recommends approval of first ustekinumab biosimilar Uzpruvo
- FDA approves first interchangeable ustekinumab biosimilar Wezlana
Research
- Biological therapies for psoriasis: evaluating durability and persistent benefits
- Switches between biosimilars and their reference products
- Latin America's biosimilars market: regulatory, institutional, and technological aspects
- Impact of trastuzumab biosimilars use in metastatic HER2-positive breast cancer
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