US pharma giant Pfizer announced on 23 April 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of its trastuzumab biosimilar. Then Sandoz, part of Novartis, announced on 2 May 2018 that its biosimilar rituximab application had also been rejected.
- 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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