The US Food and Drug Administration (FDA) announced on 9 October 2018 that it had released new guidance documents as part of its efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines.
- 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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