Blog
RSS FeedPosted by Michael Wonder on 15 Jun 2020
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 ...
Posted by Michael Wonder on 12 Jun 2020
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 ...
Posted by Michael Wonder on 11 Jun 2020
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). ...
Posted by Michael Wonder on 10 Jun 2020
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 ...
Posted by Michael Wonder on 09 Jun 2020
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, ...
Posted by Michael Wonder on 04 Jun 2020
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. ...
Posted by Michael Wonder on 29 May 2020
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 ...
Posted by Michael Wonder on 26 May 2020
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. ...
Posted by Michael Wonder on 24 May 2020
Fresenius Kabi’s regulatory submission for pegfilgrastim biosimilar accepted for review by EMA
22 May 2020 - Fresenius Kabi announced today that the EMA has accepted for review the company’s marketing authorisation application for ...
Posted by Michael Wonder on 21 May 2020
Proposal to award sole supply of infliximab in DHB hospitals
21 May 2020 - PHARMAC is proposing to award sole supply of infliximab, a biologic medicine used to treat a ...
Posted by Michael Wonder on 20 May 2020
Coverage for biosimilars vs reference products among US commercial health plans
19 May 2020 - The greater use of biosimilars may have the potential to help reduce drug costs. ...
Posted by Michael Wonder on 12 May 2020
Investigators propose different measures for biosimilar equivalence
12 May 2020 - Investigators use the HERITAGE trial findings to argue for a more precise way of measuring clinical equivalence ...
Posted by Michael Wonder on 08 May 2020
Celltrion’s Remsima SC launches in Netherlands
7 May 2020 - Subcutaneous rheumatoid arthritis treatment Remsima SC launched in the Netherlands, its third European market, Celltrion Healthcare ...
Posted by Michael Wonder on 05 May 2020
Teva and Celltrion Healthcare announce the launch of Truxima (rituximab-abbs) injection for rheumatoid arthritis, the only biosimilar to Rituxan (rituximab) available in the United States for this indication
4 May 2020 - Truxima is also now available for the treatment of granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis. ...
Posted by Michael Wonder on 15 Apr 2020
Merck announces US launch of Ontruzant (trastuzumab-dttb), a biosimilar of Herceptin (trastuzumab)
15 April 2020 - Merck today announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic ...