Biological drugs should be subject to generic competition in the US after seven years, the Obama administration said, calling it a ‘generous compromise’. Brand-name companies have lobbied for 12 to 14 years of exclusivity, while Mr Waxman proposed only five. As reported by Bloomberg News, access to cheaper copies of medicines made by biotechnology companies is ‘a key element’ in reducing healthcare costs, White House officials said in a letter to Representative Henry Waxman. “Lengthy periods of exclusivity will harm patients by diminishing innovation and unnecessarily delaying access to affordable drugs,” it said.
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Generics
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- 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
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Biosimilars
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- FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli
- 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
- Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
- Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
- Biosimilars in inflammatory bowel disease: are we ready for multiple switches
- Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
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