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The European Pharmacopoeia (Ph. Eur.) has published its first monoclonal antibody (mAb) medicinal product monograph for the IgG1-antibody based TNF-alpha antagonist, Golimumab injection (3187).
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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
- Japan approves Samsung-Nipro’s ustekinumab biosimilar
- FDA approves denosumab biosimilar Ponlimsi
- EMA recommends approval of three new biosimilars for diabetes and autoimmune conditions
- EMA recommends approval for pertuzumab and tocilizumab biosimilars
Research
- Biosimilar aflibercept (AVT06) pre-filled syringe promises safer, faster eye injections
- OECD study finds no direct link between advertising rules and biosimilar uptake
- Reaching ESG goals in pharmaceutical development
- What is the future for the US biosimilar interchangeability designation
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