What could a country like the U.S. and big payers like the Aetna’s, UnitedHealthcare’s, or even the PBMs like CVS learn from what other countries have done to garner savings for their healthcare systems and potentially reduce costs for patients?
In addition to understanding what influences employers’ health plan decision-making, it’s important to note employers' growing demands for greater pricing transparency and the complexity posed by the lack of an integrated benefits system.
When Trevena, Inc. needed to establish a supply chain for its lead compound, OLINVO (oliceridine injection) — a pain-management product expected to make the transition from clinical trial material to full-blown commercial manufacturing — executives at the emerging biopharma decided to try a new framework. Instead of simply relying on decades of collective experience in managing drug supply chains, they augmented that experience with a new set of tools developed by FDA officials and industry professionals under the Xavier University Supply by Design (SbD) Initiative.
It’s been hard to miss some of the good buzz coming out of the U.K. as the acceptance and adoption of biosimilars continues to be one of the strongest across Europe, and the NHS published its highly anticipated framework to help guide the use of biosimilars. But how the new framework will shape the U.K. biosimilar market is only just being seen.
Many have predicted payers will be the stakeholders to carry biosimilars across the finish line. But as the past few years will attest, this has not turned out to be the case, and this realization leaves the biosimilar industry asking an important, somewhat nerve-wracking question:
Of the 17 biosimilar products litigated under BPCIA to date, in most cases (about 70 percent), the applicants engaged in and completed the patent dance before the lawsuits (setting aside allegations of noncompliance with the disclosure requirements). So far, in three instances, the biosimilar applicants have declined to dance outright.
The first of this three-part article touches on the current biosimilar-related developments ongoing in the U.K., as well as what the new chair of the British Biosimilars Association (BBA) is keeping her eyes on, both in the U.K. and globally.
The Biologics Price Competition and Innovation Act of 2009 (BPCIA), enacted in March 2010, provides for an elaborate process of information exchange — known as the “patent dance” — between a biosimilar applicant and a reference product sponsor (RPS) intended to resolve potential patent disputes in an orderly and expeditious fashion.
Over the past year, sweeping regulatory reforms have been introduced in China with the aim of encouraging innovation and reducing regulatory burden on the life sciences industry. The breadth of these reforms spreads across multiple stages of the drug development life cycle.
Prescription drug spending increases — fueled by high launch prices for new therapies and price increases for existing brand-name drugs — are contributing to unsustainable healthcare cost growth across the country. In addition to straining the healthcare system overall, high drug prices also place financial burdens on patients who rely on prescription medicines to treat and manage serious and chronic medical conditions.
By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
Practical approaches to preventing aggregation in sterile injectables: Causes of protein aggregation and the role of stress testing. Part one of a three-part series.
Biosimilar expert, Amanda Turner, provides and an overview of the current state of biosimilars, covering questions such as what is a biosimilar as well as how many are in the market and are in development.
Biosimilar KOL, Dr Paul Rhyne, Chief Scientific Officer and Vice President of Bioanalytical Operations Biologics Development Services (BDS), provides and an overview of the current state of biosimilars and their global impact.
Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.
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