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
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
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Biosimilars
News
- FDA approves pegfilgrastim and rituximab biosimilars
- Byooviz: first ophthalmology biosimilar launches in US
- Biocon: cancer biosimilar launch in Canada and US$90 million Malaysia deal
- Canada approves five biosimilars in last seven months
Research
- No trends in biosimilars uptake levels in the US, reveals study
- The impact of biosimilar insulins on public spending in Brazil
- Challenges with implementing benefit-sharing programmes for biologicals in Europe
- Successful increase of biosimilar adoption in a large integrated health delivery network
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