Hikma Pharmaceuticals Plc and Civica Rx announced a five-year agreement on 23 July 2019. Under the agreement, Hikma will manufacture and supply 14 essential sterile injectable medications for Civica. It will use Hikma's abbreviated new drug applications (ANDAs) and Civica's labelling and National Drug Code (NDC). The full list of medications included in the agreement, that are often in short supply in US hospitals, will be publicly announced in the near future. Initial shipments are expected by the end of 2019.
- INICIO
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Genéricos
Novedades
- 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
Investigación
- 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
General
- Crecimiento de medicamentos genéricos en Brasil y Venezuela
- EMA launches European shortages monitoring platform to tackle persistent medicine shortages
- Penetración de los medicamentos genéricos en México y Brasil
- FDA releases one-year progress report for the Generic Drug Cluster
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Biosimilares
Novedades
- FDA approves denosumab biosimilar Degevma
- EMA recommends approval for biosimilar omalizumab Adcomfo and pertuzumab Pebrilzo
- Canada approves multiple denosumab and ustekinumab biosimilars as global competition grows
- FDA approves Zimrixby (rituximab) and Garzulys (insulin aspart) biosimilars
Investigación
- El HHS equipara biosimilares a genéricos y desata rechazo
- Biosimilar interchangeability: a necessary fix, but not a silver bullet
- EULAR 2025 RA guidelines streamlined as biosimilar expansion reshapes treatment sequencing
- Adopción de biosimilares en Chile: ¿Por qué se demora?
General
- FDA publishes draft strategy on interchangeable biosimilars following 2025 public workshop
- Medicines for Europe calls for Biotech Act reforms to address ‘biosimilar void’
- Biosimilars approved in Europe
- La SBR publica un posicionamiento sobre la intercambiabilidad segura entre biológicos originales y biosimilares
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