On 10 January 2021, the Peruvian Ministry of Health (Ministerio de Salud del Perú, MINSA), which is in charge of leading the National and Decentralised Health System, the policy for the universal health assurance and the policies and intersectoral actions on social determinants, published in the Official Gazette Diario Oficial El Peruano the supreme decree 002-2021-SA that approves the regulation for the Conditional Health Registration of Medicines and Biological Products.
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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
- 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
- EMA recommends approval for four denosumab biosimilars: Obodence, Osenvelt, Stoboclo, Xbryk
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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