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US FDA accepts biologics license application from Lupin for pegfilgrastim biosimilar expresspharma
June 03, 2021
Lupin announced that the US FDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.
Biocon Biologics to offer its Oncology Biosimilars through Cancer Access Partnership in over 30 countries expresspharma
February 05, 2021
Biocon has signed an agreement with the Clinton Health Access Initiative (CHAI) to expand access to lifesaving cancer biosimilars in over 30 countries in Africa and Asia as a part of the Cancer Access Partnership (CAP).
Biocon Biologics receives EU GMP Certification for multiple Biosimilars manufacturing facilities in expresspharma
May 20, 2020
These facilities are used for the manufacture of DS and DP for Biosimilars: Bevacizumab, Trastuzumab, Pegfilgrastim and secondary packaging of Insulin Glargine for EU markets.
Biocon and Mylan launch fulphila — biosimilar to pegfilgrastim, in Canada expresspharma
April 29, 2020
The approval of fulphila was based on a comprehensive package of analytical, non-clinical and clinical data, which confirmed that the product is highly similar to neulasta and no clinically meaningful differences in terms of safety and efficacy exist.
Sandoz resubmits BLA for biosimilar pegfilgrastim to FDA pharmaceutical-technology
April 23, 2019
Sandoz resubmits BLA for biosimilar pegfilgrastim to FDA
Napp launches pegfilgrastim biosimilar in the UK pharmatimes
April 04, 2019
Napp Pharmaceuticals has launched Pelmeg in the UK, marking the group's first launch of a product developed by Cinfa Biotech, acquired by the Mundipharma network of independent associated companies in October last year.
US OKs first biosimilar of Amgen's Neulasta pharmatimes
July 12, 2018
Mylan and Biocon's Fulphila has become the first biosimilar of Amgen's Neulasta to be approved by the US Food and Drug Administration.
EMA accepts marketing authorization applications for Mylan and Biocon’s proposed biosimilars biospectrumasia
December 04, 2017
European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Applications for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim
Sandoz proposed biosimilar pegfilgrastim accepted by EMA europeanpharmaceuticalreview
October 30, 2017
Sandoz has announced that its biosimilar pegfilgrastim has been accepted by the EMA for regulatory review…
FDA Accepts Biologics License Application (BLA) for Mylan and Biocon's Proposed Biosimilar Pegfilgra americanpharmaceuticalreview
February 17, 2017
Mylan and Biocon announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta® (pegfilgrastim), for filing through the 351(k) pathway.