Generics/News
Chinese company makes copy of patented coronavirus treatment remdesivir
China’s BrightGene has successfully produced remdesivir, an experimental treatment for coronavirus, however, patents for the drug are currently held by the American company Gilead.
EMA recommends four new generics
At the Committee for Medicinal Products for Human Use’s (CHMP) January 2020 meeting, the Committee recommended four new generics, and one new biosimilar, for approval.
FDA approves generics for cancer and gout
The US Food and Drug Administration (FDA) has approved two generic versions of Novartis’ anticancer drug Afinitor (everolimus), alongside a generic of Takeda’s gout treatment Uloric (febuxostat).
FDA approves MS and prostate generics
The US Food and Drug Administration (FDA) in December 2019 approved the first generics of Gilenya (fingolimod) for multiple sclerosis (MS) and Rapaflo (silodosin) for benign prostatic hyperplasia.
EMA recommends approval for two new generics
The European Medicines Agency’s (EMA) human medicines committee recommended seven new medicines for approval at its November 2019 meeting, including two generics: clopidogrel/acetylsalicylic acid and deferasirox.
Dubai’s LIFEPharma signs historic agreement with Canada’s Apotex
LIFEPharma, a wholly-owned subsidiary of the United Arab Emirates (UAE)-headquartered VPS Healthcare, has announced a historic agreement with Apotex Inc, Canada’s largest producer of generic drugs.
Glenmark and Lupin gain FDA approval for nervous system agents
Indian generics maker Glenmark Pharmaceuticals has been granted tentative US Food and Drug Administration (FDA) approval for its multiple sclerosis (MS) generic, while generics giant Lupin Ltd has also received FDA approval for its Dilantin generic, an anti-seizure medication.
Alimta and Orfadin generics approved by FDA
The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cancer drug Alimta, and approved Novitium Pharma’s generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).
EMA approves leukaemia and multiple myeloma generics
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 20 September 2019 that it had recommended granting marketing authorization for hypertension and leukaemia and multiple myeloma generics.
FDA approves Farxiga generic
The US Food and Drug Administration (FDA) has given tentative approval to Novartis for their generic version of AstraZeneca’s diabetes medicine Farxiga (dapagliflozin). Patent issues, however, must be resolved before FDA grants full approval.
