The U.S. Supreme Court recently issued two decisions related to inter partes review (IPR). This article will briefly introduce IPR, discuss the Supreme Court’s decisions, explain how these decisions may impact IPR and biosimilar companies, and suggest how biosimilar companies should respond.
It takes more to enter the biosimilar business than simply being a leading innovator in the biologics space. As several Pfizer experts shared, there are some integral transitions, both in mindset and in terms of practice, that need to occur to fully embrace biosimilars.
This two-part article explores the use of various tools and the emergence of intelligent solutions in the industry.The first part provides an overview of how technological advancements and data analytics are critical in enabling regulators and the life sciences industry.
In my previous article, I argued that biosimilar companies must engage states as partners for successful U.S. market access. This article accepts that premise and also assumes interchangeability will occur at the federal level. My goal is to provide insights, along with several solutions for biosimilar companies to engage local politicians and patients in a manner that is mutually beneficial. This analysis is based on reading and assessing all 38 of the local statutes addressing biosimilars and my prior experience proposing statutes for local legislatures.
A U.S. House-passed version of the Continuing Resolution (CR) threatened to remove an integral tool for biosimilar reimbursement under Medicare Part B. Though this tool (pass-through status) will remain for biosimilars, this ultimately raises questions about the importance of pass-through status and how eliminating it could impact the industry as a whole.
This article assumes interchangeability will inevitably happen in the United States at the federal level. This inference is based on the direct efforts of FDA Commissioner Scott Gottlieb to increase access for patients to biosimilars, along with other actions by the FDA, such as writing interchangeability guidelines to facilitate approval.
In the second of this two-part article, McKesson Specialty Health's Omar Hafez and Pete Perron discuss how to approach the complex financial landscape in the clinic and help incentivize clinics to use biosimilars.
Real-world evidence (RWE) has become increasingly important for innovative manufacturers looking to convince reluctant payers that their new medicine has a place in patient care. Indeed, many claim the changing nature of the data landscape in healthcare will revolutionize the way we consider evidence, but does this apply to biosimilars? Is there a real need to look at data from actual clinical practice before or after market entry for these products?
Since I will be unable to attend the upcoming Biosimilar Medicines Conference this year, I welcomed the opportunity to speak with Mylan's and the Biosimilar Medicines Group's Erin Federman about which topics she hopes to see discussed and how certain conversations surrounding biosimilars could be reframed.
At a recent press conference, Pfizer executives shared a few key updates related to Inflectra’s uptake and the ongoing efforts to work with commercial payers. These updates not only shed more light on Inflectra’s market journey, but also reassured me that progress is being made — even though it’s not regularly broadcast in headlines.
Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, method of sterilization, and considerations for high-shear mixing.
In this e-book, you’ll find insight and advice from some of the industry’s top experts about current trends in biomanufacturing, modern process intensification techniques and the outlook for digital automation. We’ll explore innovative process approaches that can be applied at various scales and stages of development in hopes of providing you with a visionary guide of how to effectively manufacture your molecule.
A third-party study was conducted to compare the performance of Thermo Scientific™ Nunc™ Roller Bottles (1.2 and 2.5X) and 850 cm2 roller bottles from another supplier, for the culturing of ST, Vero, and MDBK cells.
A rapid, flexible, and high-yield approach both hybridoma expansion and for antibody production using a serum-free medium in Nunc PETG Roller Bottles.
How product design influences biopharmaceutical manufacturer extractable profiles.
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