The advent of biological medicines has significantly transformed the landscapes of many disease spaces and improved the lives of millions around the world. However, the structural complexity and sensitivity of such products result in a high price tag, adding to already financially strained healthcare systems. As these and other expensive complex drugs lose market exclusivity, stakeholders eagerly await the arrival of lower cost alternatives, such as biosimilars and follow-on non-biological complex drugs (NBCDs). Nevertheless, stakeholders remain uncertain about key issues which have resulted in heterogeneous reimbursement policies and varying levels of biosimilar uptake and differences in the approval processes for follow-on NBCDs between different markets.
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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
- 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
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
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Biosimilars
News
- FDA approves third ustekinumab biosimilar Pyzchiva
- FDA approves first eculizumab biosimilar Bkemv for two rare diseases
- EMA recommends approval of biosimilar bevacizumab Avzivi
- EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva
Research
- Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
- Efficacy and safety of the proposed P043 (Zerafil) vs reference omalizumab in allergic asthma
- Tocilizumab and pembrolizumab biosimilar advances for Korean firms
- Unveiling key clinical findings for denosumab biosimilar candidates
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