Celltrion and its partner Teva were dealt a significant blow today, as the Korean manufacturer announced that the latest two biosimilar candidates were rejected by the Food and Drug Administration (FDA). As first reported by Dan Stanton in the Biopharma Reporter, the FDA issued complete response letters as a result of inspection problems uncovered at … Continue reading Teva and Celltrion Receive Rejections on Trastuzumab and Rituximab Biosimilars
Tag: Amgen
Fourth Herceptin® Biosimilar Being Evaluated by FDA
The end of 2017 has been bustling with oncology biosimilar news. On December 20, 2017, the Food and Drug Administration (FDA) accepted Samsung Bioepis’ application for SB3, its biosimilar version of trastuzumab. The drug would be the fourth to undergo evaluation by the FDA, and may pack on the pressure for Mylan and Biocon’s product … Continue reading Fourth Herceptin® Biosimilar Being Evaluated by FDA
Fuzzy Patent Logic
Three other biosimilar manufacturers have already filed for approval in the US: Amgen/Allergan and Celltrion/Teva (separately) in July 2017; Mylan/Biocon in November 2016. Roche settled its patent claims against Mylan in March 2017, which provides Mylan with a license to sell its biosimilar version of Herceptin® should it gain FDA approval next year.
News in the Courts on Biosimilars
According to a Reuters report, Janssen Biotech withdrew its patent lawsuit against Samsung Bioepis on November 10. The suit alleged infringement in the manufacture of Samsung’s infliximab biosimilar. The action, which was filed in U.S. District Court of New Jersey, means that Merck and Samsung, which launched Renflexis™ in July, is no longer at risk … Continue reading News in the Courts on Biosimilars
Amgen/Allergan Score Positive EMA Evaluation, but Launch Will Be Delayed
The European Medicines Agency s drug evaluation arm, the Committee for Medicinal Products for Human Use, recommended approval of the biosimilar bevacizumab on November 9.
Sandoz’s Pegfilgrastim Biosimilar Under New Review at EMA
On October 27, Sandoz announced that the European Medicines Agency has accepted its re-application for review of its biosimilar version of Neulasta® as supportive treatment in patients receiving cytotoxic chemotherapy. Sandoz’s attempt to bring its biosimilar pegfilgrastim to the market was stalled in the US in Q2 2016, when the FDA issued a complete response … Continue reading Sandoz’s Pegfilgrastim Biosimilar Under New Review at EMA
The FDA Rejects Mylan/Biocon’s Pegfilgrastim; Market Still Awaits a Biosimilar for Neulasta
In the latest blow to those seeking an alternative to Amgen’s Neulasta®, the Food and Drug Administration (FDA) sent a complete response letter to Biocon, citing manufacturing plant deficiencies, in its rejection of their biosimilar pegfilgrastim application.
Are We Now Thinking “Authorized Biosimilars”?
Authorized generics have been around for a couple of decades. They can be a challenge to payers, health systems, and patients who are seeking the price-reduction benefits borne out of normal competition. The Amgen–Abbvie agreement on the biosimilar for Humira® seems to be right out of this playbook.
Amgen Receives Approval for Bevacizumab Biosimilar
The Food and Drug Administration announced today the approval of the first biosimilar for Roche’s Avastin®. The approval of Mvasi™ (bevacizumab-awwb) represents the first biosimilar approved in the US for the direct treatment of cancer. Amgen is partnered with Allergan in the development and marketing of the new biosimilar.
Two New Trastuzumab Biosimilars Submitted for FDA Approval
The team of Mylan and Biocon may have some company in the biosimilar competition for Herceptin® (trastuzumab). Two additional partnerships announced the filing of their 351(k) applications for trastuzumab biosimilars. Amgen and Allergan are hoping ABP 980 will have smooth sailing through the approval system. The phase 3 study in patients with early-stage HER2-positive breast … Continue reading Two New Trastuzumab Biosimilars Submitted for FDA Approval