On January 18, Sandoz and Biocon announced a new biosimilar partnership, which could extend both manufacturers’ market presence. Although the specific biosimilar targets were not specified, the firms indicated that they will work to develop and commercialize next-generation oncology and immunology biosimilars. Unlike other partnerships that are delineated along the lines of manufacturing and marketing, … Continue reading Sandoz and Biocon Partner on Next-Gen Biosimilars
Tag: Biocon
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
Mylan/Biocon Receive First Approval for Trastuzumab Biosimilar, but First to Market?
On December 1, the team of Mylan and Biocon received their first biosimilar approval in the US, for an agent to compete with Roche’s Herceptin®. The approval decision on this product was delayed 3 months owing to potential issues involving Biocon’s manufacturing facility. However, this marks the first biosimilar approved for trastuzumab, beating entries from … Continue reading Mylan/Biocon Receive First Approval for Trastuzumab Biosimilar, but First to Market?
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.
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.
The Week in Biosimilar News
You know it’s been a pretty desperate week in the biosimilar blogosphere when twitter feeds relate back to articles published in January, rehashes of the US Supreme Court decision in June, or yet another estimate of the savings potentially ascribed to biosimilar use (based on erroneous assumptions). However, there were a few significant tidbits announced last week that are worth reviewing.
Mylan and Biocon Withdraw Two EMA Biosimilar Applications
This action could potentially create considerable problems for the partners Mylan and Biocon. They have the opportunity to be first-to-market in the US with regard to both biosimilar products.
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