News

• Pfizer to produce generic COVID-19 pill in eight countries of Latin America
• First eslicarbazepine epilepsy generic to be approved in China
• Pfizer and Merck COVID-19 antiviral progress
• Sun Pharma and Dr Reddy’s generics progress in EU and US

Research

• Call for drug pricing transparency
• High price of cancer medicines make treatment unaffordable globally
• US brand-name drug market exclusivity periods remain relatively unchanged over the past decade
• Considerations for the evaluation of generic IUDs containing levonorgestrel

General

• Medicines repurposing project launched in Europe
• MPP agreements allow generics production of Merck and Pfizer’s COVID-19 treatments
• FDA closes Zhejiang Huahai Pharmaceutical warning letter
• FDA reaches 100 generics approvals

News

• Canada approves adalimumab biosimilars Simlandi and Yuflyma
• Canada approves filgrastim biosimilar Nypozi
• Etanercept biosimilars delayed until 2029 in US
• New Zealand announces funding for adalimumab biosimilar

Research

• Biological standardization of bevacizumab: impact on global harmonization of potency assessment
• Real-world data cannot replace post-approval confirmatory trials
• Differences in clinical studies and pharmacovigilance of biological drugs in Latin America
• Regulations of the registration of biosimilars in Latin America

General

• Biosimilars approved in Europe
• Biosimilars applications under review by EMA – January 2022
• Biosimilars approved in Brazil
• British Columbia expands biosimilar switching programme to include insulin

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