On 12 June 2019, Certara announced that its Simcyp physiologically-based pharmacokinetic (PBPK) modelling and simulation technology successfully demonstrated the bioequivalence of a complex generic drug. This has led to US Food and Drug Administration (FDA) approval of the drug on the agency’s abbreviated new drug application (ANDA) pathway.
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
- Revlimid (lenalidomide) generics launch across Europe
- Cancer and diabetes generic treatments receive positive opinion from EMA’s CHMP
- Pricing and reimbursement of medicines in Canada
- Medicines pricing conditions in Italy and Brazil: comparison of regulations
- Relevance of NTI to the treatment of epilepsy
- What is the meaning of a narrow therapeutic index?
- EC approves bevacizumab biosimilar Vegzelma
- FDA accepts application for high concentration adalimumab biosimilar
- EC approves ranibizumab biosimilar Ranivisio
- Applications for natalizumab biosimilars accepted by FDA and EMA
- Recommendations to address challenges to biosimilars in Latin America
- Regulatory landscape for biosimilars in Latin America
- Totality of evidence for biosimilar pegfilgrastim Ziextenzo
- What does the designation of interchangeability for biosimilars in the US mean?
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