When news came my way in early December that the Biosimilars Forum had established the Biosimilars Roundtable, which would be a working group comprising members of 40 different stakeholder organizations, I was thrilled.
As we enter 2019, editorial board experts share their thoughts on what challenges will be top-of-mind for biosimilar companies, trade groups, and payers, as we progress into the new year.
As the industry matures, I’m finding it harder and harder to single out one specific news headline as being the most influential. Rather, each of these Top 5 encompasses a series of events that, together, have further defined and carried this industry forward.
In the first of what will be two articles on this topic, I unpack some of the most impactful real-world evidence releases or efforts implemented over the past year, as well as which of the biggest biosimilar questions were answered over the past year.
Using what The Coalition’s President and CEO Troy Ross has termed “3D thinking” through the creation of data mapping, employers are gaining access to information they’ve never been privy to before that will enable them to identify savings opportunities and better design their benefits — which could mean increased traction for biosimilars.
CMS has announced a new payment model that seeks to reduce out-of-pocket costs for patients. This payment model arises out of the Trump administration’s American Patients First Blueprint that was released earlier this spring. CMS is providing this notice of its proposed payment model via an Advance Notice of Proposed Rulemaking (ANPRM), meaning a formal proposed rule will be introduced in the near future. Comments close on this ANPRM on Dec. 31, 2018.
In the second of this three-part "Ask the Board" series, Biosimilar Development's editorial board members discuss their predictions on how biosimilar development, market access, commercialization efforts, and regulatory and reimbursement policies will evolve in 2019.
This article presents trends and findings from a survey and study of 222 responsible individuals at biopharmaceutical manufacturers and CMOs in 22 countries, as well as over 130 direct suppliers of materials, services, and equipment to this industry.
In the second part of this two-part article, I unpack how the FDA could solve one particularly challenging market barrier and why we should expect to see (and call for) more from other government agencies in 2019.
In the first part of a three-part “Ask The Board” series, members of the editorial board share what left them feeling the most heartened or concerned in 2018 and what must take center stage as we head into 2019.
Biosimilar purification costs constitute more than half of the total development costs. A significant number of these costs are due to the expense of Protein A–based media. This application note proposes an alternate but equally effective approach to biosimilar purification, by substituting a less expensive ion exchange resin for the affinity capture step.
Too often, marketers lack vital information to create an effective marketing strategy and your organization and department suffer due to constant disruption of marketing plans.
Single-use technology is well-established, and has made its way into commercial licensed facilities, but there is more innovation in this field which will further enhance its versatility into new markets and technologies. The closed-system ballroom manufacturing approach will enable biomanufacturers to take full advantage of the flexibility offered by single-use systems, while driving out risk and is particularly suitable for applications that require multiple or rapid change-overs, and therapies with small scale production.
The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment. Using a combination of financial options analysis and decision analytics to quantify your options helps to embrace the uncertainty equation.
The development of a robust and consistent bioprocess requires a systematic and risk-based approach to identify the right process parameters and raw materials.
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