Samsung Bioepis’ deepening ties with Teva has yielded a new deal for its etanercept biosimilar Eticovo. Under the new agreement, Teva will obtain US commercialization rights to etanercept-ykro. The timing of Eticovo’s commercial launch in the US will be determined by Teva, accordin to the press release.
Tag: etanercept
In Canada, Mandated Biosimilar Switching Again Shines Spotlight on Need for Education
The Canadian province of British Columbia mandated on May 27 that patients receiving public coverage who are using reference insulin glargine, infliximab, and etanercept therapies must be switched to biosimilars in the next 6 months. This has caused a predictable flaring of tempers, and generated some opposition on my Twitter feed. The article in the … Continue reading In Canada, Mandated Biosimilar Switching Again Shines Spotlight on Need for Education
Second Etanercept Biosimilar Receives FDA Approval
Samsung Bioepis scored another biosimilar approval in the US, as the Food and Drug Administration gave its nod to etanercept-ykro on April 25, 2019. Formerly known as SB4, Samsung Bioepis dubbed this agent Eticovo™. It is the second Enbrel® biosimilar to to receive US approval. This approval covered all of the reference product’s autoimmune … Continue reading Second Etanercept Biosimilar Receives FDA Approval
More Clinical Study Evidence That Biosimilar Switching Carries a Low Risk
A literature review published this past weekend in Drugs reaffirms what most parties interested in biosimilars suspect—that switching from a reference product to biosimilar is not a significant clinical concern. Biosimilar switching was not generally associated with poorer outcomes. The study evaluated the results of 90 clinical studies comprising more than 14,000 patients with 14 … Continue reading More Clinical Study Evidence That Biosimilar Switching Carries a Low Risk
What Will Cost Savings on 2023 Adalimumab Biosimilars Really Be Worth?
AbbVie executives are sticking to their pledge to restrict annual price increases on Humira® below 10%, but even payer price protections won’t mitigate the increasing expenditures before adalimumab biosimilars hit the market. In 2023, when adalimumab biosimilars become available, the savings biosimilars represent may not be real savings at all. Pharmaceutical companies generally seek to … Continue reading What Will Cost Savings on 2023 Adalimumab Biosimilars Really Be Worth?
A Profile on Lesser-Known Player in the Biosimilar Space: Lupin Pharmaceuticals
On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Pfizer. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this … Continue reading A Profile on Lesser-Known Player in the Biosimilar Space: Lupin Pharmaceuticals
Biosimilar Rituximab Under FDA Review
Celltrion announced June 30, 2017 that it has submitted its 351(k) application to the Food and Drug Administration for approval of its biosimilar version of rituximab. This represents the first biosimilar application for rituximab, a monoclonal antibody to CD20.
No Clear Winner on Supreme Court’s Biosimilar Hearing Day
Despite the fact that the arguments at Wednesday's Supreme Court wrestling match on the patent dance and 180-day notification issue went into overtime, there was no clear winner discernable in Amgen v. Sandoz.
Frustration Mounts as Sandoz’s Etanercept Biosimilar Launch Delayed into 2018
Call it irritation, exasperation, or frustration, but biosimilar manufacturers and payers alike are feeling it, as the fight over drug patents has barred the way to approval for yet another biosimilar for a costly biologic. In this case, Sandoz’s Erelzi™, which was approved by the Food and Drug Administration on August 30, 2016, has been … Continue reading Frustration Mounts as Sandoz’s Etanercept Biosimilar Launch Delayed into 2018