Mylan and Fujifilm Kyowa Kirin Biologics announce U.S. FDA approval of Hulio (adalimumab-fkjp)

9 July 2020 - Mylan and Fujifilm Kyowa Kirin Biologics today announced that the U.S. FDA has approved Hulio (adalimumab-fkjp), ...

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Remove the disincentives and biosimilars will flourish, policy expert says

7 July 2020 - Patients could save as much as 17% on out-of-pocket costs if they used biosimilars, but many ...

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Use of infliximab biosimilar in Medicare population is low but growing

7 July 2020 - Slow growth of use of biosimilar infliximab in a Medicare fee-for-service population suggests lingering hesitancy on the ...

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First adalimumab biosimilar gains approval in Japan

30 June 2020 - Fujifilm Kyowa Kirin Biologics said it has received Japanese regulatory approval to manufacture and market the ...

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Samsung Bioepis receives positive CHMP opinion for Aybintio (bevacizumab)

26 June 2020 - Abbintio, a biosimilar candidate referencing Avastin (bevacizumab), is Samsung Bioepis’ second oncology biosimilar to be recommended for ...

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Sandoz Canada launches the biosimilars generation

25 June 2020 - Campaign provides needed, fact-based, information for patients, healthcare providers and Canadians about biosimilar medicines in Canada. ...

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Looking back, UK patients unhappy with adalimumab biosimilar switch

24 June 2020 - The UK results show how challenging switching to a biosimilar can be, according to patient groups. ...

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Rising costs explain why Canada is switching to biosimilars

15 June 2020 - Following in the footsteps of British Columbia, other Canadian provinces are working to implement their own biosimilars ...

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Mylan and Biocon announce U.S. FDA approval of Semglee (insulin glargine injection)

11 June 2020 - FDA approval marks a significant milestone to help increase access and affordability of insulin for the millions ...

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FDA approves Pfizer's oncology supportive care biosimilar Nyvepria (pegfilgrastim-apgf)

11 June 2020 - Pfizer today announced the United States FDA has approved Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim). ...

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Sandoz Canada receives Health Canada approval to launch two oncology biosimilars: Ziextenzo and Riximyo

9 June 2020 - These two approvals mark an important milestone for Sandoz Canada, bringing its biosimilars into oncology at a ...

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Mylan and Lupin receive European marketing authorisation for Nepexto, biosimilar etanercept

 4 June 2020 - Mylan and Lupin today announced that the European Commission (EC) has granted marketing authorization for Nepexto, ...

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FDA re-evaluates user fees for biosimilar reviews

4 June 2020 - Even before the pandemic, the FDA was having trouble estimating its resource needs for biosimilar application reviews. ...

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FDA accepts for review Fresenius Kabi’s first biosimilar regulatory submission for MSB11455, a biosimilar candidate of pegfilgrastim

27 May 2020 - Fresenius Kabi announced today that the U.S. FDA has accepted for review the company’s biologics license ...

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New biosimilar trastuzumab on the PBS - information for health professionals and patients

26 May 2020 - A biosimilar brand of trastuzumab (Trazimera) was listed on the PBS on 1 May 2020.  ...

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