A report carried out by several authors showed that if the launch of biotechnological drugs unleashed controversy at the time due to their novelty, those of biosimilars were even greater. Fifteen years after the launch of the first biosimilar and taking into account current regulations, the question remains as to whether they represent opportunities or risks in terms of safety, effectiveness and costs for patients, physicians and health systems. The challenges are to educate and communicate in a broad and sustained manner about scientific innovation in pharmaco-biology, the value of innovators, and the evidence of effectiveness and safety of biosimilars [1].
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Generics
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- 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
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- FDA approves aflibercept biosimilars Enzeevu and Pavblu
- EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and SteQeyma
- Canada approves trastuzumab Adheroza and ustekinumab Steqeyma biosimilars
- EMA recommends approval of ranibizumab, rituximab and trastuzumab biosimilars
Research
- Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
- Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
- Biosimilars in inflammatory bowel disease: are we ready for multiple switches
- Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
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