EMA announced on 2 May 2013 the publication of its new draft biosimilars guideline, which will revise the agency’s 2005 overarching guideline on similar biological medicinal products. The draft guideline has been released for a six-month consultation period.
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- South Korean companies to make generic Bridion and COVID-19 drugs
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Biosimilars
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- EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz
- FDA approves second strength of trastuzumab biosimilar Hercessi
- FDA approves aflibercept biosimilars Enzeevu and Pavblu
Research
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- Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
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