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.
- INICIO
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Genéricos
Novedades
- FDA approves generic teriparatide and levetiracetam
- 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
Investigación
- Generic medications in the Lebanese community: understanding and public perception
- 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
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Biosimilares
Novedades
- Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
- EMA recommends approval of ustekinumab biosimilar Pyzchiva
- La FDA aprueba el biosimilar intercambiable de adalimumab Simlandi
- EC approval of ranibizumab biosimilar Rimmyrah
Investigación
- Cuestionando la necesidad de evaluaciones de sensibilidad étnica para anticuerpos monoclonales biosimilares
- ANVISA's role in biosimilar medicine regulation and innovation promotion
- Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
- Biological therapies for psoriasis: evaluating durability and persistent benefits
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