Despite the fact that a legal pathway for the approval of biosimilars in the US has existed for more than a year, formal guidance has still not been issued by FDA. This has led many to question when, or even if, biosimilars will come onto the market in the US . So what has FDA been doing in the meantime and how close are we to seeing some biosimilar guidance in the US?
- 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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