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How does CMS payment policy for Medicare, Medicaid, and 340B hospitals affect biosimilar uptake? A speaker at the recent at the 2020 Specialty Therapies and Biosimilars Congress explained.

Panelists at the 2020 Specialty Therapies and Biosimilars Congress discussed the strategies needed to get biosimilars to market and overcome obstacles by originator product manufacturers.

Molly Burich, MS, director of public policy for biosimilars and pipeline at the pharmaceutical giant Boehringer Ingelheim, discussed the International Price Index proposal Thursday at the 2020 Specialty Therapies and Biosimilars Congress in Miami, Florida.

In a wide-ranging state-of-the-industry talk, the clinical operations manager for Blue Cross Blue Shield of Michigan discussed pending legislation, electronic prior authorization (ePA), and biosimilar uptake, among other prominent issues Wednesday at the 2020 Specialty Therapies and Biosimilars Congress in Miami, Florida.

It’s important to keep in mind the successive patents that can be filed to keep an original product in a position of market dominance, and drug descriptions in biologic license applications can be written cleverly to achieve this aim, according to a panelist speaking at the Specialty Therapies and Biosimilars Conference, happening January 22-24, 2020, in Miami, Florida.

The company's announcement of an aggressive launch calendar at the JP Morgan Healthcare Conference in San Francisco last week was followed by Celltrion’s announcement this week that it plans to open a large biologics manufacturing plant in Wuhan, China.

The leading generic drug manufacturer launched Truxima, a biosimilar for rituximab, in November 2019 at a 10% discount to the reference product, Rituxan.

Gilead Science’s new chairman and chief executive officer outlined a growth plan this week at the J.P. Morgan Healthcare Conference in San Francisco, California.

As the only anti–tumor necrosis factor therapies currently available to US patients with inflammatory diseases, biosimilars of infliximab are increasingly used to treat diseases like rheumatoid arthritis. While there are a wealth of data on real-world use of these products in territories like the European Union, less research has examined their use in the United States. During the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, researchers reported on the results of 3 studies that assessed real-world use of biosimilar infliximab in the US context.

The lead author said the results indicate that biologics can be used in older patients with rheumatoid arthritis (RA) as effectively as in those who are younger.

While US patients continue to wait for a biosimilar etanercept to become commercially available, real-world data continue to amass for Samsung Bioepis’ biosimilar, SB4, in European clinical practice. The biosimilar, sold as Benepali in the European context, was the subject of several studies presented this week at the American College of Rheumatology’s 2019 meeting, held in Atlanta, Georgia.

Among the first biosimilars to gain US approval was Sandoz’s etanercept biosimilar, GP2015, or Erelzi. The product was authorized by the FDA in 2016, but it has not yet launched in the US market due to long-running patent disputes related to Amgen’s innovator product, Enbrel. In other markets, however, the biosimilar is a widely used treatment option, and data presented at the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, show that not only is the biosimilar safe and effective in real-world practice in ex-US markets, but it could also bring about substantial savings in the United States once it becomes available.

The results will inform will inform counseling and management of pregnant women with inflammatory diseases who need tofacitinib or non-tumor necrosis factor inhibitors during pregnancy, said the author.

Improvements in biosimilars—ones that may give them an advantage such as lower immunogenicity or a new route of administration—may be the key to unlocking a better patient experience, according to Celltrion. In fact, pursuing such so-called “biobetters” may prove to be more important for the drug maker than pursuing interchangeable biosimilars.

During the FT Global Pharmaceutical and Biotechnology Conference, held this week in London, United Kingdom, a panel of executives from pharmaceutical companies, together with a scientist whose focus is on economics, discussed the increasingly challenging problem of paying for innovative therapies, particularly in a context of heightened political pressure around high drug costs.

Postmarket drug price changes alone accounted for most of the recent spending growth on biologics, and manufacturers’ rebates had little impact, according to an abstract presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, this week.

Over the past few years, awareness of biosimilars has been increasing; however, research presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, shows that while US rheumatologists hold growing awareness of biosimilars, hesitancy remains around such issues as switching stable patients and the extrapolation of indications.

On Sunday, during the American College of Rheumatology (ACR)’s 2019 meeting, being held in Atlanta, Georgia, researchers reported on the safety and efficacy of the proposed infliximab biosimilar ABP 710 in a phase 3 study of patients with rheumatoid arthritis (RA). Researchers also reported on a phase 1 and 3 study of the proposed rituximab biosimilar, ABP 798, in patients with RA.

The great promise of biosimilars is their ability to provide high-quality treatment at a reduced cost, thereby producing cost savings that can be reapplied. But how are healthcare systems around the globe utilizing those cost savings? During the International Society for Pharmacoeconomics and Outcomes Research 2019 meeting, held this week in Copenhagen, Denmark, several teams of researchers reported on how biosimilars are impacting international markets, and how they could provide headroom for new, expensive treatments.

France has experimented with financial incentives to reward the prescribing of biosimilars. These incentive structures include shared savings for centers that acquire medicines at lower costs, as well as biosimilar prescribing targets.

During the International Society for Pharmacoeconomics and Outcomes Research 2019 meeting being held in Copenhagen, Denmark, 3 teams of researchers presented findings that show that, despite the fact that Europe’s biosimilars market is far more mature than that of the United States, the region still sees setbacks from stakeholder perceptions of biosimilars and from policies that do not adequately incentivize biosimilar use.

The International Society for Pharmacoeconomics and Outcomes Research is holding its Europe 2019 meeting this week in Copenhagen, Denmark, and the savings that biosimilars can afford European healthcare systems are a hot topic at this year’s event. Two studies presented on Monday explored how Amgen’s biosimilar bevacizumab (Mvasi) and biosimilar trastuzumab (Kanjinti) could produce significant cost savings for hospitals in the Italian healthcare system.

“Talk about the success first,” said Steinar Madsen, MD, medical director of the Norwegian Medicines Agency. “Forget the nonexistent problems.”

In the US context, legal issues surrounding patents are often cited as one of the main hurdles to biosimilars. Despite the fact that patents on innovator drugs are often fewer in Europe, the patent landscape in the European Union remains complex and continues to evolve. During the SMi 10th Annual Biosimilars Conference, Gregory Bacon, DPhil, GDipIPLaw, partner at Bristows LLP, gave attendees a closer look at one emerging feature of the EU patent landscape that is of particular concern to biosimilar developers: the Arrow declaration.

Innovation is not always the first term that comes to mind with respect to biosimilars; after all, having no clinically relevant differences between products is at the heart of biosimilarity. However, as Sebastian Maag, device project leader for Novartis–Sandoz GmbH, told attendees during the second day of the SMi 10th Annual Biosimilars Conference, biosimilar developers have the opportunity to introduce innovations with the design of their devices for drug delivery.

If and when the United Kingdom leaves the European Union, the Medicines and Healthcare Products Regulatory Agency is poised to provide its own review structure for biosimilars.

The global biosimilars market is beginning to take on a more defined shape as blockbuster therapies lose their exclusivities, the United States sees the entrance of the first anticancer biosimilars, and Europe gains experience and savings with adalimumab biosimilars. But what will the coming decade hold in terms of new development projects and global sustainability?

During the opening day of the SMi 10th Annual Biosimilars Conference, held September 25-26 in London, United Kingdom, Dan Cohen, Biogen’s regional senior director of biosimilars for the United Kingdom, Ireland, and the Netherlands, shared his experience with anti–tumor necrosis factor biosimilars in general, and with biosimilar adalimumab in particular, in the EU marketplace.

Industry insiders discuss current trends about the patent dance and other issues, as well as proposed legislation that could affect biosimilar development.

Courts will be busy with biosimilar litigation for the foreseeable future, attorneys predicted at a panel on the second day of the ACI 10th Summit on Biosimilars.