The first pegfilgrastim biosimilar (Fulphila™) in the US has begun marketing, and Mylan/Biocon are offering a 33% discount to the wholesale acquisition cost (WAC) of the originator product Neulasta®. The Center for Biosimilars reported a communication from Mylan confirming the action. This is a watershed moment for the pegfilgrastim category and could signal the beginning of … Continue reading Mylan’s Fulphila Pegfilgrastim Biosimilar Launches at Big Discount
Tag: Amgen
An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?
Momenta seems to be in final preparations for its first 351(k) filing to the Food and Drug Administration (FDA). In its recent investor conference, the company disclosed that it is ready to send M923, its adalimumab biosimilar, to the agency for approval. Despite this promising news, Momenta is facing strong headwinds. Even if it gains … Continue reading An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?
Mylan and Biocon Land First Pegfilgrastim Biosimilar Approval
The race to bring a pegfilgrastim biosimilar to market officially started on December 17, 2014. The checkered flag fluttered 3½ years later on June 4, 2018, with the Mylan/Biocon team winning on a slow track. The partners earned approval from the US Food and Drug Administration (FDA), becoming the first biosimilar to challenge for this … Continue reading Mylan and Biocon Land First Pegfilgrastim Biosimilar Approval
FDA Approval Eludes Amgen for Biosimilar Trastuzumab
Amgen will have to wait a bit longer to market its biosimilar version of trastuzumab . On Friday, June 1, the Food and Drug Administration (FDA) rejected Amgen’s 351(k) application for its Herceptin® biosimilar. In a brief press release, Amgen announced receiving the complete response letter for ABP 980. In the announcement, it also said that the … Continue reading FDA Approval Eludes Amgen for Biosimilar Trastuzumab
What Is the Biosimilar Pegfilgrastim Market Opportunity?
We’ve covered the contest to bring a biosimilar pegfilgrastim to market, with considerable depth. The progress and setbacks of Mylan/Biocon, Coherus Biosciences, Sandoz, and Apotex have been tracked. Other drug makers are also working on plans towards 351(k) applications for approval. Eventually—likely sooner than later—one or two will hit the market. Biosimilar Pegfilgrastim, Neulasta®, and … Continue reading What Is the Biosimilar Pegfilgrastim Market Opportunity?
Trastuzumab Dosing May Be Given in Half the Time: Will Costs/Revenues Be Cut as Well?
An upcoming presentation at the annual American Society of Clinical Oncology (ASCO) meeting promises equal efficacy and much improved safety for patients with early-stage breast cancer receiving Herceptin®. This change in trastuzumab dosing from a 12-month to a 6-month regimen will have ramifications for patients, health systems, and manufacturers. A number of biosimilar drug makers … Continue reading Trastuzumab Dosing May Be Given in Half the Time: Will Costs/Revenues Be Cut as Well?
Coherus Biosciences Shows Major Stock Gain Upon BLA Resubmission
When it received a June 2017 complete response letter from the Food and Drug Administration (FDA), the outlook for Coherus Biosciences was cloudy. Its lead product, a biosimilar for pegfilgrastim (CHS-1701), had been cited for the way the drug maker evaluated immunogenicity and for manufacturing plant issues. Upon receiving the news, it cut 30% of … Continue reading Coherus Biosciences Shows Major Stock Gain Upon BLA Resubmission
FDA Hands Sandoz a Rejection on Its Rituximab Biosimilar
Sandoz announced today that the Food and Drug Administration (FDA) has decided not to approve its biosimilar version of the oncology biosimilar rituximab. The content of the complete response letter was not revealed by Sandoz. This marks the second rituximab biosimilar rejected by the FDA. Celltrion and Teva’s Truxima™ was also rejected in early April. … Continue reading FDA Hands Sandoz a Rejection on Its Rituximab Biosimilar
Pfizer Receives FDA Rejection on Trastuzumab, Next up Is Amgen/Allergan
When Pfizer announced that it received a complete response letter from the Food and Drug Administration (FDA), the wait for an available biosimilar to Herceptin® just got longer. According to the manufacturer, the FDA specified that the reasons for the rejection of PF-05280014 were not related to clinical questions. The rejection was not associated with … Continue reading Pfizer Receives FDA Rejection on Trastuzumab, Next up Is Amgen/Allergan
With the Samsung Bioepis Deal, Abbvie Tightening Its Grip on the US Adalimumab Market
Samsung Bioepis and Biogen has reached a deal with Abbvie that would enable it to market its biosimilar adalimumab (should it be granted approval) in June 2023. This is the second deal Abbvie has made with a potential competitor, confirming the solidity of its patent wall. The European patent expires in October 2018, and competitors … Continue reading With the Samsung Bioepis Deal, Abbvie Tightening Its Grip on the US Adalimumab Market