COVID-19 and the supply and distribution of generic and biosimilar prescription medicines in Canada

1 April 2020 - The following is a statement from Jim Keon, President of the Canadian Generic Pharmaceutical Association (CGPA) ...

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Biosimilars could disappear if the Supreme Court overturns the ACA

1 April 2020 - With the sense of urgency rightly focused on slowing or stopping the spread of COVID-19, it ...

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Pfizer receives European approval for oncology biosimilar Ruxience (rituximab)

2 April 2020 - Pfizer today announced that the European Commission has approved Ruxience (rituximab), a monoclonal antibody and biosimilar to ...

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Mylan and Lupin announce positive CHMP opinion for Nepexto, biosimilar etanercept

27 March 2020 - Mylan and Lupin today announced that the EMA's CHMP has adopted a positive opinion recommending the ...

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Samsung Bioepis announces FDA approval of 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb)

24 March 2020 - 150 mg and 420 mg vial of Ontruzant are now approved. ...

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Biosimilar pegfilgrastim on the PBS - information for health professionals and patients

24 March 2020 - The first biosimilar brand of pegfilgrastim (Ziextenzo) has listed on the PBS on 1 March 2020.  ...

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Teva and Celltrion Healthcare announce U.S. availability of Herzuma (trastuzumab-pkrb) for injection

16 March 2020 - Teva Pharmaceuticals USA and Celltrion Healthcare today announced that Herzuma (trastuzumab-pkrb) for Injection, a biosimilar to Herceptin, ...

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HHS Secretary Alex Azar expresses hope in biosimilar uptake, notes positive momentum

11 March 2020 - HHS Secretary Alex Azar discussed the future of biosimilars in the United States and the actions taken ...

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PhRMA: federal biosimilar payment policies are having a positive effect

4 March 2020 - Katie Verb, director of policy and research for the biopharmaceutical industry group PhRMA, discusses recent policy changes ...

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U.S. FDA accepts biologics license application for Mylan and Biocon's proposed biosimilar bevacizumab for review

9 March 2020 - Biocon and Mylan today announced that the U.S. FDA has accepted Mylan’s biologics license application for ...

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Celltrion applies for European approval of Humira biosimilar

9 March 2020 - Celltrion said Monday that it applied for the European Medicine Agency’s commercialization approval of CT-P17, a ...

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Five years on, biosimilars need support from all health care players

6 March 2020 - Today marks a milestone for the U.S. biosimilar market: the FDA approved our first biosimilar, Sandoz’s ...

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Alberta’s switch to biosimilar drugs may pose legal challenges for doctors

24 February 2020 - Prescribing cheaper medications for arthritis, diabetes or Crohn’s disease could be at odds with physicians’ legal requirement ...

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FDA launches new Purple Book searchable database to help patients and prescribers identify FDA-approved biologic and biosimilar treatment options

24 February 2020 - Today, the FDA is releasing the first phase of the enhancement of the “Purple Book: Database of ...

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Understanding the role of comparative clinical studies in the development of oncology biosimilars

14 February 2020 - Biosimilars have the potential to broaden patient access to biologics and provide cost savings for health care ...

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