The US Food and Drug Administration (FDA) announced on 11 December 2018 that it had released four guidance documents and a proposed rule on the definition of a ‘biological product’.
- 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
- Revlimid (lenalidomide) generics launch across Europe
- 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?
- Australia and EU: Alvotech Humira and Stada Lucentis biosimilars approved
- Advances for Alvotech’s partnerships in Japan, Canada and Switzerland
- Progress for Lucentis (ranibizumab) biosimilars in Europe and the US
- Bevacizumab biosimilar approvals and launch in Japan and USA
- Investigating biosimilar product drift and divergence
- Biosimilars, are they comparable to their reference counterparts?
- The cost savings of non-medical switching in dermatology
- Switching from adalimumab originator and ABP501 to SB5 in arthritis patients
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