On February 5, Merck announced that it will create a new spinoff that will include its biosimilar business with Samsung Bioepis as well as its legacy pharmaceuticals (e.g., Zetia®, Vytorin®, and other widely diversified brands). In its press release, Merck emphasized that the as-yet unnamed new company will also have a strong focus on women’s … Continue reading Merck to Spin Off Company That Will Include Its Biosimilar Marketing in 2021
Tag: Merck
Samsung Bioepis Scores FDA Approval of Ontruzant, the Third Biosimilar Trastuzumab
The US Food and Drug Administration (FDA) announced on January 18, 2019 the approval of a new biosimilar version of trastuzumab. Produced by Samsung Bioepis, this agent was dubbed Ontruzant (trastuzumab-dttb). This is the third trastuzumab biosimilar approved by the FDA, following those by Mylan and Biocon in December 2017 (Ogivri®) and Teva and Celltrion … Continue reading Samsung Bioepis Scores FDA Approval of Ontruzant, the Third Biosimilar Trastuzumab
Celltrion’s Rituximab Biosimilar Earns Positive Review
The information package released by reviewers for the Food and Drug Administration (FDA) indicates that a positive recommendation for Celltrion’s rituximab biosimilar is likely at the Advisory Committee meeting on October 10. The members of the Oncologic Drugs Advisory Committee will review the data and hear public comments before voting to recommend that the FDA … Continue reading Celltrion’s Rituximab Biosimilar Earns Positive Review
Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate
A long-sought dream in the United States will be a welcome reality in Europe this October: a stampede for Abbvie’s marketshare with adalimumab biosimilars and the savings that go with it. Four or possibly five manufacturers will be lined up in the starting gate. Fujifilm Kyowa Kirin Biologics and its marketing partner Mylan have not … Continue reading Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate
Infliximab Biosimilars Savings Could Exceed $400 Million Dollars Annually
Everyone with an opinion believes that biosimilar drug use will save the health system considerable money. Calculations for biosimilar savings have been hampered by several factors. For example, previous high estimates have not been based on real-life scenarios. Only 3 biosimilars have been launched and utilized in the US; so little experience has been gained on which … Continue reading Infliximab Biosimilars Savings Could Exceed $400 Million Dollars Annually
Plans Use Step Therapy to Encourage Utilization of Remicade Over Biosimilars
Health plans and insurers are not yet turning to biosimilar infliximab as a preferred therapy, according to Gillian Woollett, DPhil, MA, of Avalere. Her new report surveyed publicly available policy about health plans across the nation. The principal finding was that step therapy was commonly used to encourage use of the originator product. In fact, … Continue reading Plans Use Step Therapy to Encourage Utilization of Remicade Over Biosimilars
Pfizer US Biosimilar Revenues Growing Slowly, Better News Internationally
According to an article posted on the Market Realist website, Pfizer’s US and global biosimilars revenues are growing, but its sales of Inflectra® remain stunted. In the fourth-quarter of 2017, the New York–based company posted US biosimilar revenues of $44 million—all attributable to its infliximab biosimilar. The product was launched in Q4 2016 (and gained … Continue reading Pfizer US Biosimilar Revenues Growing Slowly, Better News Internationally
Pfizer’s At-Risk Launch of Inflectra Pays Off (at Least a Bit)
The US Court of Appeals handed Pfizer a big victory in its gamble to bring its biosimilar version of Remicade® to the market before the completion of patent litigation. On January 23, the Appeals Court ruled that Johnson & Johnson’s ‘471 patent in the case was declared invalid, clearing the way for sales of Inflectra® … Continue reading Pfizer’s At-Risk Launch of Inflectra Pays Off (at Least a Bit)
A Pre-Holiday Gift for Pfizer—a Second Infliximab Biosimilar Approval. Now What?
On December 14, Pfizer got an early Christmas present, the approval by the Food and Drug Administration (FDA) of the second infliximab biosimilar in which it has a stake. First came Inflectra® in 2016, and here comes Ixifi™ (infliximab-qbtx). Unlike Inflectra, which Pfizer markets for Celltrion, Ixifi is Pfizer’s alone—a product that was under development … Continue reading A Pre-Holiday Gift for Pfizer—a Second Infliximab Biosimilar Approval. Now What?
A Health System Biosimilar Survey’s Implications
When asked about potential cost savings with the infliximab biosimilar, nearly one-quarter of health system respondents did not believe that it represented a cost savings opportunity for their organization, according to a newly published survey in the Journal of Managed Care and Specialty Pharmacy. Conducted by Premier, Inc., a group purchasing organization, 57 US health … Continue reading A Health System Biosimilar Survey’s Implications