The primary safety concern for biosimilar agents is their potential immunogenicity. Using biopharmaceuticals to replace endogenous proteins that may be present at insufficient concentrations carries the serious risk of stimulating the immune system to develop anti-product antibodies (Abs), which may cross-react with endogenous protein.
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Generics
News
- 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
- Cancer and diabetes generic treatments receive positive opinion from EMA’s CHMP
Research
- The cost of developing drugs and use of generics
- Re-evaluation of the use of generics, especially when treating conditions such as epilepsy
- Repurposing generic drugs can save time and money
- Availability of medicines and the sustainable development of the national health system in Russia
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Biosimilars
News
- Lucentis biosimilars approved in the UK and Korea
- New adalimumab biosimilars prepare to launch in Canada, US and Europe
- FDA approves Amneal’s bevacizumab biosimilar
- Europe: positive opinion for Inpremzia and Truvelog Mix 30 and Stimufend authorized
Research
- Patient perspectives on biosimilars in a high uptake country
- Biosimilar adoption and prescribing in Japan: a physician opinion survey
- Innovent and Eli Lilly announce final results for sintilimab plus biosimilar bevacizumab injection
- Totality of evidence supporting approval of Avsola in the treatment of IBD
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