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US OKs first biosimilar of Amgen's Neulasta pharmatimes
June 06, 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.
Out of the FDA doghouse, Celltrion again seeks Rituxan biosimilar nod fiercepharma
May 31, 2018
Celltrion, trying to get back on track with two biosimilars it shares with Teva, is returning to the FDA with its versions of the blockbuster cancer treatments.
A Description of the Market Data of the 9 Marketed Biosimilars in the U.S. Dopine
May 28, 2018
The marketing of many biosimilars has met resistance in the U.S. recently as FDA sent CRLs for them.
Sandoz US woes continue with biosimilar rejection pharmafile
May 04, 2018
In Novartis’ recently released Q1 results, which largely beat analysts’ estimates, Sandoz was a black spot on its record – with sales of the generics unit down by 18%.
FDA rejects Pfizer Herceptin biosimilar, wants technical info pharmaphorum
April 25, 2018
A Pfizer-produced biosimilar of Roche’s blockbuster breast cancer drug, Herceptin, has been rejected by US regulators.
The FDA Giveth and Taketh Away: Grants Pfizer's MenB Breakthrough Therapy Designation and Turns Down a Biosimilar biospace
April 24, 2018
The U.S. Food and Drug Administration (FDA) granted Pfizer’s Trumenba, a vaccine for meningococcal B disease in children ages one to nine years, Breakthrough Therapy Designation.
JHL Biotech submits application for Bevacizumab Biosimilar biospectrumasia
April 18, 2018
Once approved, JHL1149 will be manufactured at JHL's facility in Wuhan, China
Mylan, Biocon to launch Adalimumab Biosimilar in EU biospectrumasia
April 16, 2018
FKB’s product is at an advanced stage of review and could potentially obtain approval in Europe in the second half of 2018.
Biogen, Bioepis resolve dispute over Humira biosimilar biospectrumasia
April 08, 2018
AbbVie will grant patent licenses for the biosimilar, branded as IMRALDI, in Europe on a country-specific basis.
Biogen, Bioepis resolve dispute over Humira biosimilar biospectrumasia
April 08, 2018
AbbVie will grant patent licenses for the biosimilar, branded as IMRALDI, in Europe on a country-specific basis.

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