This article explains why having the right and option to seek declaratory relief is still important to a biosimilar applicant despite the patent resolution mechanism provided by BPCIA, examines the limitations on declaratory judgment actions imposed by BPCIA, and discusses recent court cases addressing biosimilar applicants’ rights to declaratory relief.
Conversations about biosimilars amongst stakeholders are beginning to shift in the way that we’d like them to. The industry no longer needs to (stringently) justify the science so much as provide information on how the product can be used. One expert shares some recent revelations she plans to turn into actionable strategies in her role at Mylan and with Medicines for EU.
As biosimilars are targeting drugs with more than $5 billion in annual revenue, the originator manufacturers desperately need to find ways to either defend or replace that revenue. Strategies have included portfolio contracting, rebating, patent pursuits, supply chain differentiation, licensing deals, and building customer loyalty.
In many situations, value is associated with the price tag, and, specifically, the savings associated with a certain product. But there are still questions of how biosimilar value can be presented to stakeholders, especially since it can feel as though there is a missing part in the equation.
Patents are the most important requirement for successful biologic commercialization, yet stakeholders often have little understanding of the unique obstacles encountered in this field, especially for biosimilars. Biologics may treat less than 2 percent of the U.S. population, but they account for 38 percent of all U.S. prescribed drug spending.
Though none of the regulatory issues discussed will be resolved right away, you can guarantee these will become regular parts of the dialogue between the industry and regulators in the years ahead.
The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency.
As Julie Maréchal-Jamil of Medicines for Europe shared, the biggest questions in Europe now circle around sustainability — particularly whether market policies, procurement mechanisms, and benefit sharing models are in sync with the system's needs, and if they can teach nations that have yet to seize the biosimilar opportunity.
Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.
When it comes to biosimilars, building confidence that these medicines can deliver the same experience as a branded medicine will ultimately require more than communicating successful clinical trial results. Here, we unpack several strategies patient advocacy groups have indicated to be essential for successfully reaching patients.
Using a shared biomanufacturing facility, a biomanufacturer can minimize its investment while mitigating the risks of demand uncertainty and maximizing time to market.
Trevor Marshall of Zenith Technologies discusses the impact that multi-product manufacturing facilities, single-use technologies, continuous manufacturing and industry 4.0 will have on automation.
Complete transparency and open communication are critical for a successful partnership. What business practices should you look for to ensure your CDMO can offer this type of commitment?
Over the life of a drug, changes in raw materials are almost inevitable. But even a small modification can throw your drug out of compliance. Using case studies, the author explains how to safeguard drug integrity when raw materials change.
Flow cytometry introduces a powerful and versatile technology into studies, enabling in-depth analysis of cell signaling and behavior.
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