The pharmaceutical industry in Germany is facing price cuts expected to cost the industry more than Euros 2 billion per year, where parliament is set to approve the first price controls on newly approved innovator medicines. The law gives drugmakers one year to agree a price with insurers after new drugs are introduced, but if an agreement is not reached, the German Health Ministry will set maximum pricing and the product will undergo a cost-benefit analysis.
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Generics
News
- 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
Research
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
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Biosimilars
News
- EC approves eight biosimilars, eight more await final authorization
- Canada approves first omalizumab biosimilar Omlyclo
- EMA recommends approval for tocilizumab biosimilar Avtozma and filgrastim biosimilar Zefylti
- Ustekinumab biosimilars Yesintek, Steqeyma, and Otulfi approved by FDA, EMA and Health Canada
Research
- Positive safety and efficacy primary endpoint results for AVT05 (golimumab proposed biosimilar)
- Are interchangeable biosimilars at risk?
- Comparative efficacy studies: where are we now?
- Pertuzumab biosimilar HLX11 meets primary endpoint in phase III comparative clinical study
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