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Samsung Bioepis has announced that the European Medicines Agency (EMA) has accepted for review its market authorization application for SB8, a proposed bevacizumab biosimilar referencing Avastin.

Sandoz announced today that it has enrolled its first patient in a combined phase 1 and phase 3 study of its proposed denosumab biosimilar versus EU-authorized Prolia.

At the beginning of this year, we spoke with Laura Joszt, associate editorial director and the host of The American Journal of Managed Care’s podcast, Managed Care Cast, about where biosimilars stood at the end of 2018. Now, halfway through the year, we’re continuing that conversation with a look at how biosimilars have fared so far in 2019.

Celltrion formed Vcell Healthcare Limited with Nan Fung Group with the aim of commercializing 3 biosimilars in China.

When the Senate Committee on Health, Education, Labor, and Pensions released bipartisan legislation aimed at lowering the cost of healthcare in the United States in May, biosimilar stakeholders had some cause for optimism. However, one provision of the bill that has garnered significantly less attention from the broader healthcare community has raised concerns among many biologics stakeholders.

The first anticancer biosimilars have arrived on the US market. Amgen and Allergan have announced the launch of Mvasi, a bevacizumab biosimilar referencing Avastin, and Kanjinti, a trastuzumab biosimilar referencing Herceptin, in the United States.

The Center for Biosimilars® recaps the top stories for the week of July 15, 2019.

The top 3 drugs in 2018 in the United States by spending were adalimumab, insulin glargine, and etanercept, according to a study in The American Journal of Health-System Pharmacy, which also predicted that drug spending will grow 4% to 6% this year.

According to the Congressional Budget Office (CBO), enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.

Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.

Six months after launching its biosimilar pegfilgrastim, Udenyca, Coherus BioSciences announced that it has produced more that 400,000 prefilled syringes of its product.

This week, Mylan launched its biosimilar adalimumab, Hulio, in Spain. The biosimilar, referencing Humira, was developed by Mylan’s partner, Fujifilm Kyowa Kirin Biologics, and received European authorization in September 2018.

Singapore-based Prestige BioPharma announced this week that its HD204, a proposed biosimilar bevacizumab product referencing Avastin, met its primary end point in a phase 1 study evaluating the pharmacokinetics (PK), safety, and immunogenicity of the biosimilar in comparison to its reference.

The Center for Biosimilars® recaps the top stories for the week of July 8, 2019.

Samsung Bioepis, developer of the biosimilar trastuzumab, Ontruzant, and Genentech, maker of the reference trastuzumab, Herceptin, have asked a court to dismiss their patent litigation.

The Trump administration has withdrawn its proposal to block rebates and discounts given by drug makers to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations.

The Center for Biosimilars® had a conversation with Alexandra D. Valenti, JD, of Goodwin’s Intellectual Property Litigation group, to help understand the recent discussions in the Senate Judiciary Committee about ongoing attempts at patent reform.

This week, a research letter appearing JAMA Internal Medicine reported on efforts to understand whether there exists an association between payments from drug makers and Medicare spending on adalimumab and certolizumab.

Biosimilar developer Biocon is facing yet another setback after the FDA issued another Form 483 for its insulin facility.

The United States District Court for the District of Columbia has vacated the Trump administration’s rule requiring the disclosure of wholesale acquisition costs for drugs in direct-to-consumer television advertising. The rule had been slated to take effect today, July 9.

Singapore-based Prestige BioPharma has entered into 2 new agreements related to its proposed biosimilar trastuzumab, HD201, which it hopes to sell under the brand name Tuznue.

Biosimilar developer Samsung Bioepis has gained an updated label for its biosimilar adalimumab, Imraldi, referencing Humira. The biosimilar is now approved for storage in nonrefrigerated conditions for up to 28 days. This update means that the biosimilar can now be stored for an additional 2 weeks at room temperature.

The multicenter, randomized, noninferiority, double-blind, controlled trial was conducted in China among 554 patients with active ankylosing spondylitis.

The European Commission approved ravulizumab (Ultomiris) for adults with paroxysmal nocturnal hemoglobinuria.

The Center for Biosimilars® recaps the 5 most-read stories of 2019 to date.

Two economists from the American Enterprise Institute (AEI) shot back at the idea that biosimilars are natural monopolies and should have their prices regulated by the government, as was proposed a little more than 2 months ago by critics who say that trying to wring lower drug prices through competition born from biosimilars is an experiment doomed to fail.

Amgen says it is withdrawing its European application for ABP 710, its biosimilar infliximab (referencing Remicade).

Mundipharma, a network of independent companies that operates in 120 countries worldwide and distributes a number of biosimilars in the European Union, has inked a deal with Budapest-based Egis Pharmaceuticals to distribute its biosimilar pegfilgrastim, Pelmeg, in 4 Eastern European markets: Hungary, Romania, Lithuania, and Latvia.

The FDA has approved Pfizer’s bevacizumab biosimilar, bevacizumab-bvzr, referencing Avastin.

The Center for Biosimilars® recaps the top stories for the week of June 24, 2019.