News

This month, Maryland’s Attorney General Brian Frosh petitioned the Supreme Court to uphold the “first-in-the-nation” law against drug price-gouging.

China-based drug maker Innovent Biologics has revealed that China’s National Medical Products Administration has approved its application to test a combination therapy comprising a proposed biosimilar bevacizumab product, IBI305, plus sintilimab, an anti–programmed cell death protein 1 (PD-1) monoclonal antibody.

On Friday, Mylan announced that it has launched its biosimilar adalimumab, Hulio, in the European Union. Hulio’s entrance into the marketplace brings the number of available biosimilar adalimumab therapies to 4.

Genentech announced this week that the FDA has approved an update to its reference rituximab’s (Rituxan) label.

Mylan and Biocon’s biosimilar trastuzumab, which will be sold as Ogivri and which references Herceptin, today received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

New research from Avalere suggests that moving Part B drugs into Part D could result in higher out-of-pocket costs for beneficiaries with rheumatoid arthritis (RA) unless policy changes are made to reduce Part D cost sharing.

Fresenius Kabi has become the latest biosimilar developer to enter into an agreement with Humira maker AbbVie over a biosimilar adalimumab product, MSB11022.

The Center for Biosimilars® recaps the top news for the week of October 15, 2018.

A recent study provides insight into the feasibility of at-home administration of biosimilar filgrastim—Pfizer’s recently approved Nivestym—an option that has the potential to reduce patient burden associated with hospital administration.

This week, the insurer rolled out some of the changes it will be implementing in its Medicare Advantage (MA) plans as of January 1, 2019.

Ireland’s Medicines Management Program (MMP), a body that promotes cost-effective drug prescribing, has opened a consultation related to its roadmap for prescribing best-value biologics in the Irish healthcare setting. Under the roadmap, the MMP will review the use of currently reimbursed anti–tumor necrosis factor (TNF) therapies, which represent the highest-expenditure category for Ireland’s reimbursement plan.

One day after Sandoz and Amgen announced European launches of their biosimilar adalimumab products referencing Humira, Samsung Bioepis announced that it has launched its own biosimilar, Imraldi.

“When we change the rules, the market players will reorganize their businesses to fit the new world. And it will be a very different world for American drug pricing," said HHS Secretary Alex Azar.

Sandoz has announced that its biosimilar adalimumab, Hyrimoz, became available today in the United Kingdom, and Amgen announced that it will begin making its Amgevita available in multiple European markets.

October 16 marks European patent expiry for AbbVie’s blockbuster anti–tumor necrosis factor drug, adalimumab (Humira), and multiple competitors stand ready to launch their biosimilar products on, or shortly after, that date.

Pemphigus vulgaris (PV) is a rare immune-mediated skin disorder, typically occurring in middle-aged and older adults, that involves painful blistering of the skin and mucous membranes. While many patients are well controlled on systemic corticosteroid treatment, steroid-sparing therapy can be desirable for treating moderate to severe forms of the disease, and rituximab is one such agent to show promise in this indication.

According to a filing made in the Republic of Korea, Samsung Bioepis has disclosed that Merck has terminated the companies' development and commercialization agreement for a follow-on insulin glargine product referencing Sanofi’s Lantus.

The Center for Biosimilars® recaps the top news for the week of October 8, 2018.

Kashyap Patel, MD, a medical oncologist at Carolina Blood and Cancer Care, said after the FDA’s Oncologic Drug Advisory Committee (ODAC) hearing on CT-P10 that "Clearly, the mood has changed to be a lot more favorable for the biosimilars.”

In June, the American Medical Association's (AMA) president Barbara L. McAneny, MD, outlined the group’s concerns during a hearing held by the California Department of Insurance stating that “The AMA has come to the conclusion that this merger would likely substantially lessen competition in many healthcare markets, to the detriment of patients,” and therefore should be blocked.

On Thursday, biosimilar developer Sandoz announced that it had reached a global settlement of its patent disputes with AbbVie, maker of the reference Humira. The settlements will allow Sandoz to enter some European markets with its biosimilar adalimumab, Hyrimoz, as early as October 16, 2018.

Coherus BioSciences has launched a comprehensive website offering patients and providers support services for its biosimilars.

The paper reports findings from a study that used retrospective data from a single center in Poland from 2009 to 2014. Records from a total of 104 patients, each of whom received infliximab, etanercept, or adalimumab under the National Health Fund, were assessed.

As US healthcare increasingly moves toward value-based payment approaches, biosimilars, which reduce costs while maintaining treatment quality, can be an important driver of value. However, according to a white paper, a new framework for assessing the value of biosimilars is warranted.

In a vote on whether the totality of the evidence supported the licensure of CT-P10 as a biosimilar to Rituxan, all 16 Oncologic Drug Advisory Committee (ODAC) members voted yes, for reasons some enumerated as “overwhelming biosimilarity and clinical trial evidence” that “really sealed the deal.”

The Association of European Cancer Leagues, a nonprofit, pan-European organization of national and regional cancer societies, has issued a new white paper that calls for greater biosimilar use as a means to reduce costs and increase patient access to cancer treatment.

Mundipharma, a network of independent companies that operates in 120 countries worldwide, announced today that it has acquired biosimilar developer Cinfa Biotech. The deal will provide Mundipharma with access to B12019, a proposed biosimilar pegfilgrastim, referencing Neulasta, which received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2018.

Earlier this month, the United States, Mexico, and Canada entered into the United States–Mexico–Canada Agreement, or USMCA, an updated version of the North American Free Trade Agreement. Since the details of the agreement were released, the pharmaceutical intellectual property portions of the deal have come under scrutiny.

Drug maker Alexion says that it is preparing for regulatory submissions in the United States, the European Union, and Japan for eculizumab (Soliris) for the treatment of anti-aquaporin-4 auto antibody-positive neuromyelitis optica spectrum disorder.

Fresenius Kabi announced today that its MSB11455, a proposed pegfilgrastim biosimilar referencing Neulasta, met its primary endpoints in 2 clinical studies that are intended to facilitate regulatory applications for the product in the United States and the European Union.