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: Renflexis
How Confusing Is Biologic and Biosimilar Substitution?
Evidence is mounting, especially from Europe that biosimilars to a single reference product result in the same clinical outcomes, with no appreciable safety issues. Evidence of this type from America will take time to accumulate, because competition in categories with multiple biosimilar options has been much more limited. The recent announcement in British Columbia of … Continue reading How Confusing Is Biologic and Biosimilar Substitution?
The Biosimilar Mabs Have It: FDA Approves Biosimilars for Adalimumab and Rituxumab
In a busy beginning of the week, the US Food and Drug Administration approved new biosimilars for Humira®and Rituxan®. Samsung Bioepis gained approval for Hadlima™ (adalimumab-bwwd), and Pfizer scored with Ruxience™ (rituximab-pvvr). HADLIMA The approval for Hadlima covers the following indications: Rheumatoid arthritisJuvenile idiopathic arthritisPsoriatic arthritisAnkylosing spondylitisCrohn’s disease in adultsUlcerative colitisPlaque psoriasis Formerly known as SB5, … Continue reading The Biosimilar Mabs Have It: FDA Approves Biosimilars for Adalimumab and Rituxumab
Even Today, Patients and Payers Hold the Key to Biosimilar Uptake Success
Reading the white paper co-published March 19 by the US-based Biosimilars Forum and UK-based Medicines for Europe highlighted for me the importance of an essential roadblock to increased biosimilar uptake in the US. The white paper outlined structural market changes needed in the US to gain comparable conversion of marketshare in the European market. Without … Continue reading Even Today, Patients and Payers Hold the Key to Biosimilar Uptake Success
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
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)
Pfizer Sues J&J on Anticompetitive Practices on Infliximab in the US
Whereas Pfizer has made some inroads to the US market, since its launch at the end of 2016, Janssen has done a good job of blocking and tackling—playing the contracting game. The lawsuit claims that Janssen has withheld or threatened to withhold rebates if payers do not keep Remicade in an exclusive preferred position.